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List of Medical Devices, by Product Code,

that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices


for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

BSK - CUFF, TRACHEAL TUBE, INFLATABLE


BSZ - GAS-MACHINE, ANESTHESIA

2
2

Y
Y

N
N

BTL - VENTILATOR, EMERGENCY, POWERED


(RESUSCITATOR)

BTM - VENTILATOR, EMERGENCY, MANUAL


(RESUSCITATOR)

BTO - TUBE, TRACHEOSTOMY (W/WO


CONNECTOR)

BTR - TUBE, TRACHEAL (W/WO CONNECTOR)

BTS - TUBE, BRONCHIAL (W/WO CONNECTOR)

BWC - NEEDLE, EMERGENCY AIRWAY

BYE - ATTACHMENT, BREATHING, POSITIVE END


EXPIRATORY PRESSURE

BYK - TENT, OXYGEN, ELECTRICALLY POWERED

BYT - VENTILATOR, EXTERNAL BODY, NEGATIVE


PRESSURE, ADULT (CUIRASS)

BZR - MIXER, BREATHING GASES, ANESTHESIA


INHALATION

CAC - APPARATUS, AUTOTRANSFUSION

CAG - CIRCULATOR, BREATHING-CIRCUIT

CAO - AIRWAY, ESOPHAGEAL (OBTURATOR)

CAW - GENERATOR, OXYGEN, PORTABLE


CBF - CHAMBER, HYPERBARIC

2
2

Y
Y

N
N

CBI - TUBE, TRACHEAL/BRONCHIAL,


DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

CBK - VENTILATOR, CONTINUOUS, FACILITY USE

CBO - ATTACHMENT, INTERMITANT MANDATORY


VENTILATION (IMV)
CBP - VALVE, NON-REBREATHING

2
2

Y
Y

N
N

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

CCO - BED, ROCKING, BREATHING ASSIST

DRO - PACEMAKER, CARDIAC, EXTERNAL


TRANSCUTANEOUS (NON-INVASIVE)
DSS - CLIP, VASCULAR
DST - CLIP, VENA-CAVA

2
2
2

Y
N
N

N
Y
Y

DSW - BAG, POLYMERIC MESH, PACEMAKER

DSY - PROSTHESIS, VASCULAR GRAFT, OF 6MM


AND GREATER DIAMETER

DTD - PACEMAKER LEAD ADAPTOR

DTK - FILTER, INTRAVASCULAR,


CARDIOVASCULAR

DTM - FILTER, BLOOD, CARDIOPULMONARY


BYPASS, ARTERIAL LINE

DTP - DEFOAMER, CARDIOPULMONARY BYPASS

DTQ - CONSOLE, HEART-LUNG MACHINE,


CARDIOPULMONARY BYPASS

DTR - HEAT-EXCHANGER, CARDIOPULMONARY


BYPASS

DTX - GAS CONTROL UNIT, CARDIOPULMONARY


BYPASS

DTZ - OXYGENATOR, CARDIOPULMONARY


BYPASS

DWA - CONTROL, PUMP SPEED,


CARDIOPULMONARY BYPASS

DWB - PUMP, BLOOD, CARDIOPULMONARY


BYPASS, ROLLER TYPE

DWC - CONTROLLER, TEMPERATURE,


CARDIOPULMONARY BYPASS

DXZ - PATCH, PLEDGET AND INTRACARDIAC,


PETP, PTFE, POLYPROPYLENE

DYF - PROSTHESIS, VASCULAR GRAFT, OF LESS


THEN 6MM DIAMETER

DYX - LOCK, WIRE, AND LIGATURE, INTRAORAL

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

DZE - IMPLANT, ENDOSSEOUS, ROOT-FORM

DZK - WIRE, FIXATION, INTRAOSSEOUS

DZL - SCREW, FIXATION, INTRAOSSEOUS


ELE - IMPLANT, SUBPERIOSTEAL

2
2

N
N

Y
Y

ESF - POLYMER, COMPOSITE SYNTHETIC PTFE


WITH CARBON-FIBER, ENT

ESH - POLYMER, ENT SYNTHETIC-PIFE, SILICON


ELASTOMER, POLYETHYLENE, POLYURETHANE
ESW - PROSTHESIS, ESOPHAGEAL

2
2

N
N

Y
Y

ESX - TACK, SACCULOTOMY (CODY TACK)


ESY - PROSTHESIS, OTOPLASTY

2
2

N
N

Y
Y

ESZ - TUBE, SHUNT, ENDOLYMPHATIC

ETA - REPLACEMENT, OSSICULAR PROSTHESIS,


TOTAL

ETB - PROSTHESIS, PARTIAL OSSICULAR


REPLACEMENT
ETC - MOLD, MIDDLE-EAR
ETD - TUBE, TYMPANOSTOMY
EZX - MESH, SURGICAL, METAL
FAD - STENT, URETERAL
FAE - PROSTHESIS, PENILE

2
2
2
2
2
2

N
N
N
N
N
N

Y
Y
Y
Y
Y
Y

FEZ - CATHETER AND TUBE, SUPRAPUBIC

FGE - CATHETER, BILIARY, DIAGNOSTIC


FHS - DIALYZER, SINGLE COIL

2
2

Y
Y

Y
N

FIB - PROTECTOR, TRANSDUCER, DIALYSIS


FID - TUBING, DIALYSATE

2
2

Y
Y

N
N

FIF - SET, DIALYSIS, SINGLE NEEDLE WITH UNIDIRECTIONAL PUMP

FIG - CLAMP, TUBING, BLOOD, AUTOMATIC

FIH - PUMP, INFUSION OR SYRINGE, EXTRALUMINAL

FII - SYSTEM, DIALYSATE DELIVERY, SEALED

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

FIJ - SYSTEM, DIALYSATE DELIVERY,


RECIRCULATING, SINGLE PASS

FIK - SYSTEM, DIALYSATE DELIVERY,


RECIRCULATING

FIL - SYSTEM, DIALYSATE DELIVERY, SINGLE


PASS

FIR - PUMP, BLOOD, EXTRA-LUMINAL


FIS - FLOWMETER, DIALYSATE
FIW - ALARM, PILLOW PRESSURE

2
2
2

Y
Y
Y

N
N
N

FIZ - METER, CONDUCTIVITY, NON-REMOTE

FJB - DETECTOR, DIALYSATE LEVEL


FJC - DETECTOR, BLOOD LEVEL
FJD - DETECTOR, LEAK, BLOOD
FJF - DETECTOR, AIR BUBBLE
FJG - DIALYZER, PARALLEL FLOW
FJH - DIALYZER, DISPOSABLE

2
2
2
2
2
2

Y
Y
Y
Y
Y
Y

N
N
N
N
N
N

FJI - DIALYZER, CAPILLARY, HOLLOW FIBER


FJJ - DIALYZER, TWIN COIL

2
2

Y
Y

N
N

FJK - SET, TUBING, BLOOD, WITH AND WITHOUT


ANTI-REGURGITATION VALVE

FJS - CATHETER, PERITONEAL, LONG-TERM


INDWELLING
FJT - INTRACATHETER, DIALYSIS

2
2

N
Y

Y
N

FKB - CONNECTOR, BLOOD TUBING, INFUSION T


FKC - CLAMP, CANNULA
FKD - CANISTER, COIL
FKJ - FILTER, BLOOD, DIALYSIS
FKL - INSERT, PUMP, BLOOD
FKN - ADAPTOR, SHUNT

2
1
2
2
2
2

Y
N
Y
Y
Y
N

N
Y
N
N
N
Y

FKO - CATHETER, PERITONEAL DIALYSIS, SINGLE


USE

FKP - SYSTEM, DIALYSATE DELIVERY, SINGLE


PATIENT

FKQ - SYSTEM, DIALYSATE DELIVERY, CENTRAL


MULTIPLE PATIENT

FKR - SUBSYSTEM, PROPORTIONING

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

FKT - SYSTEM, DIALYSATE DELIVERY, SORBENT


REGENERATED

FKX - SYSTEM, PERITONEAL, AUTOMATIC


DELIVERY

FKY - CONNECTOR, TUBING, DIALYSATE

FLA - MONITOR, TEMPERATURE, DIALYSIS

FLC - STATION, DIALYSIS CONTROL, NEGATIVE


PRESSURE TYPE

FLS - MONITOR, APNEA, FACILITY USE

FTL - MESH, SURGICAL, POLYMERIC


FTM - MESH, SURGICAL

2
2

N
N

Y
Y

FTQ - PROSTHESIS, PENIS, RIGID ROD

FWP - PROSTHESIS, CHIN, INTERNAL

FZD - PROSTHESIS, EAR, INTERNAL

FZE - PROSTHESIS, NOSE, INTERNAL


FZP - CLIP, IMPLANTABLE
GAK - SUTURE, ABSORBABLE

2
2
2

N
N
N

Y
Y
Y

GAL - SUTURE, ABSORBABLE, NATURAL

GAM - SUTURE, ABSORBABLE, SYNTHETIC,


POLYGLYCOLIC ACID

GAN - SUTURE, ABSORBABLE, SYNTHETIC


GAO - SUTURE, NONABSORBABLE

2
Unclassified

N
N

Y
Y

GAP - SUTURE, NONABSORBABLE, SILK

GAQ - SUTURE, NONABSORBABLE, STEEL,


MONOFILAMENT AND MULTIFILAMENT, STERILE

GAR - SUTURE, NONABSORBABLE, SYNTHETIC,


POLYAMIDE

GAS - SUTURE, NONABSORBABLE, SYNTHETIC,


POLYESTER

GAT - SUTURE, NONABSORBABLE, SYNTHETIC,


POLYETHYLENE

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

GAW - SUTURE, NONABSORBABLE, SYNTHETIC,


POLYPROPYLENE
GDW - STAPLE, IMPLANTABLE

2
2

N
N

Y
Y

GWO - PLATE, CRANIOPLASTY, PREFORMED,


ALTERABLE

GXN - PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

GXO - STRIP, CRANIOSYNOSTOSIS, PREFORMED

GXP - METHYL METHACRYLATE FOR


CRANIOPLASTY
GXQ - DURA SUBSTITUTE
GXR - COVER, BURR HOLE

2
2
2

N
N
N

Y
Y
Y

GZB - STIMULATOR, SPINAL-CORD, IMPLANTED


(PAIN RELIEF)

GZF - STIMULATOR, PERIPHERAL NERVE,


IMPLANTED (PAIN RELIEF)

HBP - CLIP, IMPLANTED MALLEABLE

HBW - FASTENER, PLATE, CRANIOPLASTY


HCE - CLAMP, CAROTID ARTERY

2
2

N
N

Y
Y

HCG - DEVICE, NEUROVASCULAR EMBOLIZATION


HCH - CLIP, ANEURYSM

2
2

N
N

Y
Y

HFJ - PROSTHESIS, FALLOPIAN TUBE


HPZ - IMPLANT, EYE SPHERE

2
2

N
N

Y
Y

HQJ - IMPLANT, ABSORBABLE, (SCLERAL


BUCKLING METHODS)

HQM - KERATOPROSTHESIS, PERMANENT


IMPLANT
HQT - SHELL, SCLERAL

2
2

N
N

Y
Y

HQW - CLIP, TANTALUM, OPHTHALMIC

HQX - IMPLANT, ORBITAL, EXTRA-OCULAR


HRS - PLATE, FIXATION, BONE

2
2

N
N

Y
Y

HRY - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, METAL/POLYMER

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

HSB - ROD, FIXATION, INTRAMEDULLARY AND


ACCESSORIES

HSD - PROSTHESIS, SHOULDER, HEMI-, HUMERAL,


METALLIC UNCEMENTED

HSH - PROSTHESIS, KNEE, HEMI-, TIBIAL,


RESURFACING (UNCEMENTED)

HSN - PROSTHESIS, ANKLE, SEMI-CONSTRAINED,


CEMENTED, METAL/POLYMER

HSX - PROSTHESIS, KNEE, FEMOROTIBIAL, NONCONSTRAINED, CEMENTED, METAL/POLYMER

HTG - PROSTHESIS, KNEE, HEMI-, PATELLAR


RESURFACING, UNCEMENTED
HTN - WASHER, BOLT NUT
HTY - PIN, FIXATION, SMOOTH
HWC - SCREW, FIXATION, BONE

2
2
2
2

N
N
N
N

Y
Y
Y
Y

HXA - PROSTHESIS, TENDON, PASSIVE

IWG - SEED, ISOTOPE, GOLD, TITANIUM,


PLATINUM

JAZ - PROSTHESIS, FACIAL, MANDIBULAR


IMPLANT
JCQ - PROSTHESIS, ESOPHAGUS
JCS - PROSTHESIS, MAXILLA

2
2
Unclassified

N
N
N

Y
Y
Y

JCT - PROSTHESIS, TRACHEAL, EXPANDABLE

JDB - PROSTHESIS, ELBOW, SEMI-CONSTRAINED,


CEMENTED

JDC - PROSTHESIS, ELBOW, CONSTRAINED,


CEMENTED

JDD - PROSTHESIS, UPPER FEMORAL

JDG - PROSTHESIS, HIP, FEMORAL COMPONENT,


CEMENTED, METAL

JDH - PROSTHESIS, HIP, HEMI-, TRUNNIONBEARING, FEMORAL, METAL/POLYACETAL

Not
Classified

JDI - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/POLYMER, CEMENTED

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

JDJ - MESH, SURGICAL, ACETABULAR, HIP,


PROSTHESIS

JDK - PROSTHESIS, HIP, CEMENT RESTRICTOR

JDN - IMPLANT, FIXATION DEVICE, SPINAL

JDO - DEVICE, FIXATION, PROXIMAL FEMORAL,


IMPLANT

JDP - CONDYLAR PLATE FIXATION IMPLANT


JDQ - CERCLAGE, FIXATION
JDR - STAPLE, FIXATION, BONE
JDS - NAIL, FIXATION, BONE
JDT - CAP, BONE
JDW - PIN, FIXATION, THREADED

2
2
2
2
1
2

N
N
N
N
N
N

Y
Y
Y
Y
Y
Y

JEC - COMPONENT, TRACTION, INVASIVE


JEY - PLATE, BONE

2
2

N
N

Y
Y

JOF - POLYMER, ENT SYNTHETIC, POROUS


POLYETHYLENE

JOH - TUBE TRACHEOSTOMY AND TUBE CUFF

JOQ - GENERATOR, PULSE, PACEMAKER,


EXTERNAL PROGRAMMABLE

JWH - PROSTHESIS, KNEE,


PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
CEMENTED, POLYMER/METAL/POLYMER

JWI - PROSTHESIS, WRIST, 2 PART METALPLASTIC ARTICULATION, SEMI-CONSTRAINED

JWJ - PROSTHESIS, WRIST, 3 PART METALPLASTIC-METAL ARTICULATION, SEMICONSTRAINED

JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND


COMPONENTS

JXH - METHYL METHACRYLATE FOR


ANEURYSMORRHAPHY
JXI - CUFF, NERVE

2
2

N
N

Y
Y

KDA - PROSTHESIS, PTFE/CARBON-FIBER

KDI - DIALYZER, HIGH PERMEABILITY WITH OR


WITHOUT SEALED DIALYSATE SYSTEM

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KDJ - SET, ADMINISTRATION, FOR PERITONEAL


DIALYSIS, DISPOSABLE

KHJ - POLYMER, ENT SYNTHETIC-POLYAMIDE


(MESH OR FOIL MATERIAL)

KHK - POLYMER, ENT NATURAL-COLLAGEN


MATERIAL

Unclassified

KIG - PROSTHESIS, WRIST, CONSTRAINED,


POLYMER

KKY - MATERIAL, POLYTETRAFLUOROETHYLENE


VITREOUS CARBON, FOR MAXILLOFACIAL
RECONSTRUCTION

KLZ - TUBE, SHUNT, ENDOLYMPHATIC WITH


VALVE

KMB - PROSTHESIS, KNEE, NON-CONSTRAINED


(METAL-CARBON REINFORCED POLYETHYLENE)
CEMENTED

KMC - PROSTHESIS, HIP, SEMI-CONSTRAINED,


COMPOSITE/METAL

KMD - PROSTHESIS, ANKLE, SEMI-CONSTRAINED,


CEMENTED, METAL/COMPOSITE

KNR - ADAPTER, A-V SHUNT OR FISTULA


KNZ - ACCESSORIES, A-V SHUNT

2
2

N
N

Y
Y

KOB - CATHETER, SUPRAPUBIC (AND


ACCESSORIES)

KOC - ACCESSORIES, BLOOD CIRCUIT,


HEMODIALYSIS

KPF - SYSTEM, DIALYSATE DELIVERY, SEMIAUTOMATIC, PERITONEAL

KPK - MARKER, OSTIA, AORTO-SAPHENOUS VEIN


KPM - SHUNT, PERITONEAL

2
2

N
N

Y
Y

KPO - DIALYSATE CONCENTRATE FOR


HEMODIALYSIS (LIQUID OR POWDER)

KPP - PERITONEAL DIALYSATE FILTER

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KQL - TUBE, TYMPANOSTOMY WITH SEMIPERMEABLE MEMBRANE

KQQ - TUBING, DIALYSATE (AND CONNECTOR)


KQR - DETECTOR, AIR OR FOAM

2
2

Y
Y

N
N

KRD - DEVICE, VASCULAR, FOR PROMOTING


EMBOLIZATION
KRH - RING, ANNULOPLASTY

2
2

N
N

Y
Y

KRO - PROSTHESIS, KNEE, FEMOROTIBIAL,


CONSTRAINED, CEMENTED, METAL/POLYMER

KRQ - PROSTHESIS, KNEE,


PATELLO/FEMOROTIBIAL, CONSTRAINED,
CEMENTED, POLYMER/METAL/POLYMER

KRR - PROSTHESIS, KNEE, PATELLO/FEMORAL,


SEMI-CONSTRAINED, CEMENTED,
METAL/POLYMER

KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE


COMBINATION, MULTIPLE COMPONENT

KTW - APPLIANCE, FIXATION, NAIL/BLADE/PLATE


COMBINATION, SINGLE COMPONENT

KTX - PROSTHESIS, KNEE, FEMOROTIBIAL, NONCONSTRAINED, METAL/COMPOSITE CEMENTED

KWD - PROSTHESIS, TOE, HEMI-, PHALANGEAL

KWF - PROSTHESIS, FINGER, POLYMER

KWH - PROSTHESIS, TOE, CONSTRAINED,


POLYMER

KWI - PROSTHESIS, ELBOW, HEMI-, RADIAL,


POLYMER

KWK - APPLIANCE, NAIL/BLADE/PLATE


COMBINATION, SINGLE COMPONENT

KWL - PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

KWM - PROSTHESIS, WRIST, SEMI-CONSTRAINED

10

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

KWN - PROSTHESIS, WRIST, CARPAL LUNATE

KWO - PROSTHESIS, WRIST, CARPAL SCAPHOID

KWP - APPLIANCE, FIXATION, SPINAL


INTERLAMINAL

KWQ - APPLIANCE, FIXATION, SPINAL


INTERVERTEBRAL BODY

KWS - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER CEMENTED

KWT - PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

KWY - PROSTHESIS, HIP, HEMI-, FEMORAL,


METAL/POLYMER, CEMENTED OR UNCEMENTED

KWZ - PROSTHESIS, HIP, CONSTRAINED,


CEMENTED OR UNCEMENTED, METAL/POLYMER

KXA - PROSTHESIS, HIP, FEMORAL, RESURFACING

KXE - PROSTHESIS, WRIST, HEMI-, ULNAR

KXK - SOURCE, BRACHYTHERAPY, RADIONUCLIDE

KXM - SYSTEM ACCESSORIES, EXTRACORPOREAL


KYF - IMPLANT, EYE VALVE

2
2

Y
N

N
Y

KYI - PROSTHESIS, WRIST, CARPAL TRAPEZIUM

KYJ - PROSTHESIS, FINGER, CONSTRAINED,


POLYMER

KYK - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, METAL/COMPOSITE

LBL - TUBE, TYMPANOSTOMY, POROUS


POLYETHYLENE

LBM - POROUS POLYETHYLENE OSSICULAR


REPLACEMENT

LBN - REPLACEMENT, TOTAL OSSICULAR,


PROSTHESIS, POROUS, POLYETHYLENE

11

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

LBP - REPLACEMENT, OSSICULAR (STAPES)


USING ABSORBABLE GELATIN MATERIAL

LCJ - EXPANDER, SKIN, INFLATABLE

Unclassified

LDD - DC-DEFIBRILLATOR, LOW-ENERGY,


(INCLUDING PADDLES)

LDF - ELECTRODE, PACEMAKER, TEMPORARY

LEM - HUMAN LYOPHILIZED DURA MATER


LFB - BUTTON, NASAL SEPTAL
LFK - CATHETER, FEMORAL

2
Unclassified
2

N
N
Y

Y
Y
Y

LGE - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED, CEMENTED, TRUNNION-BEARING

LGK - PROSTHESIS, MAXILLOFACIAL

Not
Classified

LHG - ELECTRODE, SPINAL EPIDURAL

LJS CATHETER,INTRAVASCULAR,THERAPEUTIC,LONGTERM GREATER THAN 30 DAYS

LJT - PORT & CATHETER, IMPLANTED,


SUBCUTANEOUS, INTRAVASCULAR

LKG - PORT & CATHETER, IMPLANTED,


SUBCUTANEOUS, INTRAVENTRICULAR

Unclassified

LLB - SYSTEM, BLOOD, EXTRACORPOREAL AND


ACCESSORIES

LLD - PORT & CATHETER, IMPLANTED,


SUBCUTANEOUS, INTRAPERITONEAL
LOD - BONE CEMENT

Unclassified
2

N
N

Y
Y

LPH - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/POLYMER, POROUS UNCEMENTED

LPK - BONE GRAFTING MATERIAL, FOR DENTAL


BONE REPAIR

LQS - SPERMATOCELE, ALLOPLASTIC

Unclassified

12

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

LRI - PH METER FOR DIALYSIS HYDROGEN ION


CONCENTRATION

LWJ - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/POLYMER, UNCEMENTED

LXT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE


COMBINATION, MULTIPLE COMPONENT, METAL
COMPOSITE

LYC - BONE GRAFTING MATERIAL, SYNTHETIC

LYP - ACCESSORIES, FIXATION, SPINAL


INTERLAMINAL
LYT - FIXATION ACCESSORY

2
2

N
N

Y
Y

LZJ - PROSTHESIS, TOE


(METATARSOPHALANGEAL), JOINT,
METAL/POLYMER, SEMI-CONSTRAINED
LZK - IMPLANT, MALAR
LZN - CEMENT OBTURATOR

Unclassified
Unclassified
2

N
N
N

Y
Y
Y

LZO - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/CERAMIC/POLYMER, CEMENTED OR NONPOROUS, UNCEMENTED

LZY - PROSTHESIS, HIP, HEMI-, FEMORAL, METAL


BALL

MAH - HEARING AID, BONE CONDUCTION,


IMPLANTED

MAL - GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC


COMPOSITE

MAX - INTERVERTEBRAL FUSION DEVICE WITH


BONE GRAFT, LUMBAR

MAY - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/CERAMIC/POLYMER, CEMENTED OR NONPOROUS CEMENTED, OSTEOPHILIC FINISH

MAZ - PROSTHESIS, HIP, SEMI-CONSTRAINED,


METAL/POLYMER, POROUS UNCEMENTED,
OSTEOPHILIC FINISH
MBB - BONE CEMENT, ANTIBIOTIC

Not
Classified
2

N
N

Y
Y

MBF - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER, UNCEMENTED

13

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MBH - PROSTHESIS, KNEE,


PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED,
UNCEMENTED, POROUS, COATED,
POLYMER/METAL/POLYMER

MBI - FASTENER, FIXATION, NONDEGRADABLE,


SOFT TISSUE

MBL - PROSTHESIS, HIP, SEMI-CONSTRAINED,


UNCEMENTED, METAL/POLYMER, POROUS

MBM - PROSTHESIS, HIP, SEMI-CONSTRAINED OR


HEMI-, METAL/PTFE COATED/POLYMER,
CEMENTED OR UN-CEMENTED

Not
Classified

MBP - FILLER, BONE VOID, OSTEOINDUCTION (W/O


HUMAN GROWTH FACTOR)

MBV - PROSTHESIS, KNEE,


PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED,
UHMWPE, PEGGED, UNCEMENTED,
POLYMER/METAL/POLYMER

MBZ - INSTRUMENT, ELECTROSURGICAL, FIELD


FOCUSED
MCA - TAPE, SURGICAL, INTERNAL
MCH - CLIP, HEMOSTATIC

Not
Classified
Unclassified
2

N
N
N

Y
Y
Y

MDL - IMPLANT, TRANSMANDIBULAR

MDO - FIBRILLATOR, AC, INTERNAL

2
Not
Classified

MDV - PORT & CATHETER, INFUSION, IMPLANTED,


SUBCUTANEOUS, INTRASPINAL

Not
Classified

MDX - PORT & CATHETER, INFUSION, IMPLANTED,


SUBCUTANEOUS, INTRAPERITONEAL

Not
Classified

MEH - PROSTHESIS, HIP, SEMI-CONSTRAINED,


UNCEMENTED, METAL/POLYMER, NON-POROUS,
CALICUM-PHOSPHATE

MEJ - PROSTHESIS, HIP, SEMI-CONSTRAINED,


COMPOSITE/POLYMER

Not
Classified

MFC - CATHETER, OCCLUDING,


CARDIOVASCULAR, IMPLANTABLE

Not
Classified

14

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MFH - IMPLANT, INTEGRATED TISSUE

Not
Classified

MHC - PORT, INTRAOSSEOUS, IMPLANTED

MIB - ELASTOMER, SILICONE BLOCK

MIC - IMPLANT, MUSCLE, PECTORALIS

Unclassified

MIX - SYSTEM, VOCAL CORD MEDIALIZATION

MJW - PROSTHESIS, SUBTALAR, PLUG, POLYMER

Unclassified

MLB - DEVICE, REPEAT ACCESS (ABDOMEN)

Not
Classified

MLP - KERATOPROSTHESIS, TEMPORARY


IMPLANT, SURGICAL USE

MLW - WARMER, PERITONEAL DIALYSATE

MMB - HEARING-AID, TYMPANIC MEMBRANE


MAGNET
MNF - IMPLANT, TEMPORAL

Not
Classified
2

N
N

Y
Y

MNH - ORTHOSIS, SPONDYLOLISTHESIS SPINAL


FIXATION

MNI - ORTHOSIS, SPINAL PEDICLE FIXATION

MNT - VENTILATOR, CONTINUOUS, MINIMAL


VENTILATORY SUPPORT,FACILITY USE
MNU - STAPLE, ABSORBABLE

2
2

Y
N

N
Y

MOO - ORTHOPEDIC IMPLANT MATERIAL

Unclassified

MOP - ROTATOR, PROSTHETIC HEART VALVE

Unclassified

MPB - CATHETER, HEMODIALYSIS, NONIMPLANTED

MPD - AUXILLARY POWER SUPPLY (AC OR DC)


FOR LOW-ENERGY DC-DEFIBRILLATOR

MPE - AUXILLARY POWER SUPPLY (AC OR DC)


FOR EXTERNAL TRANSCUTANEOUS CARDIAC
PACEMAKER

MQN - EXTERNAL MANDIBULAR FIXATOR AND/OR


DISTRACTOR

15

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MQO - PROSTHESTIC DISC NUCLEUS DEVICE

Not
Classified

MQP - SPINAL VERTEBRAL BODY REPLACEMENT


DEVICE

MQR - STENT, COLONIC, METALIC, EXPANDABLE

MQS - SYSTEM, HEMODIALYSIS, ACCESS


RECIRCULATION MONITORING
MQU - OCULAR PEG

2
2

Y
N

N
Y

MQV - FILLER, BONE VOID, CALCIUM COMPOUND

MQY - DOWEL, SMALL JOINT, BONE FUSION

Not
Classified

MRN - APPARATUS, NITRIC OXIDE DELIVERY

MRO - APPARATUS, NITRIC OXIDE, BACKUP


DELIVERY
MRP - ANALYZER, NITRIC OXIDE

2
2

Y
Y

N
N

MRQ - ANALYZER, NITROGEN DIOXIDE

MRW - SYSTEM, FACET SCREW SPINAL DEVICE

Unclassified

MRY - APPLIANCES AND ACCESSORIES, FIXATION,


BONE, ABSORBABLE SINGLE/MULTIPLE
COMPONENT

Unclassified

MSE - HEMODIALYZER, RE-USE, LOW FLUX

MSF - HEMODIALYZER, RE-USE, HIGH FLUX

MSK - IMMUNOASSAY FOR BLOOD TACROLIMUS

Not
Classified

MSX - SYSTEM,NETWORK AND


COMMUNICATION,PHYSIOLOGICAL MONITORS
MTJ - WAX,BONE
MTZ - WRAP, IMPLANT, ORBITAL

2
Unclassified
2

Y
N
N

N
Y
Y

MUF - SYSTEM,JOINT
RESTORATION,ARTHROSCOPICALLY DIRECTED

Not
Classified

MUM - STENT,METALLIC,EXPANDABLE,DUODENAL

MUV - STIMULATOR, VAGUS NERVE, IMPLANTED,


TREMOR

Not
Classified

16

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

MUY - STIMULATOR,VAGUS NERVE,


IMPLANTED,(COMA AND VEGETATIVE STATE)

Not
Classified

MVB - FILLER, BONE VOID, MEDICATED

Not
Classified

MWX - SYSTEM,PROSTATE,MAGNETIC/THERMAL
RODS

Not
Classified

MXC - RECORDER,EVENT,IMPLANTABLE
CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)

MXD - RECORDER,EVENT,IMPLANTABLE
CARDIAC,(WITH ARRHYTHMIA DETECTION)

MXW - SUTURE, SURGICAL, NONABSORBABLE,


POLY (VINYLIDENE FLUORIDE)

MXX - GEL,CAPSULAR CONTRACTURE


REDUCTION

Not
Classified

MYV - SCREW,ODONTIOD

2
Not
Classified

MZQ - BALLOON,DETACHABLE,FOR
NEUROVASCULAR OCCLUSION

MZT - DEVICE,HEIMLICH MANEUVER ASSIST

MZZ - PROSTHESIS, FEMORAL NAIL

Not
Classified

NAJ - AGENTS,EMBOLIC,FOR TREATMENT OF


UTERINE FIBROIDS

NAP - CARDIAC SUPPORT MESH WRAP

Not
Classified

MYU - ACCESSORY,BARIUM SULFATE,METHYL


METHACRYLATE FOR CRANIOPLASTY

NAR - STIMULATOR,PERIPHERAL
NERVE,IMPLANTED (PAIN RELIEF,OCCIPITAL
HEADACHE)
NBF - PROSTHESIS,RETINAL

Not
Classified
Not
Classified

NBI - CATHETER,INTRAVASCULAR,COOLING

Not
Classified

17

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NBM - VENTILATOR,AUTOMATIC
CONTROLLER,PERCENT OXYGEN

Not
Classified

NBQ - STIMULATOR,VAGUS
NERVE,IMPLANTED,MYOCLONUS

Not
Classified

NBY - SUTURE, SURGICAL, NONABSORBABLE,


EXPANDED, POLYTETRAFLOUROETHYLENE

NCA - CLIP, IMPLANTABLE, FOR CORONARY


ARTERY BYPASS GRAFT (CABG)

NCB - WEIGHTS, EYELID, IMPLANTABLE

Not
Classified

NCH - STIMULATOR, VAGUS NERVE, IMPLANTED,


FOR TREATMENT OF OBESITY

Not
Classified

NCN - PROSTHESIS, KNEE, JOINT,


PATELLOFEMORALTIBIAL, SEMI-CONSTRAINED,
CEMENTED, CERAMIC/POLYMER/METAL

Not
Classified

NDB - STIMULATOR, VAGUS NERVE, IMPLANTED,


FOR ANXIETY

Not
Classified

NDD - CERCLAGE, FIXATION, METALLIC

NDE - ROD, FIXATION, INTRAMEDULLARY AND


ACCESSORIES, METALLIC AND NON-COLLAPSIBLE

NDF - PLATE, FIXATION, BONE, NON-SPINAL,


METALLIC

NDG - WASHER, BOLT, NUT, NON-SPINAL,


METALLIC

NDH - NAIL, FIXATION, BONE, METALLIC

NDI - STAPLE, FIXATION, BONE, METALLIC

NDJ - SCREW, FIXATION, BONE, NON-SPINAL,


METALLIC

NDK - SYSTEM, EXTERNAL FIXATOR (WITH


METALLIC INVASIVE COMPONENTS)

NDL - PIN, FIXATION, SMOOTH, METALLIC

NDM - PIN, FIXATION, THREADED, METALLIC

NDN - CEMENT, BONE, VERTEBROPLASTY

18

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NEA - CEMENT, EAR, NOSE AND THROAT


NEH - ANCHOR, FASCIAL

2
2

N
N

Y
Y

NEU - MARKER, RADIOGRAPHIC, IMPLANTABLE

NEW - SUTURE, SURGICAL, ABSORBABLE,


POLYDIOXANONE

NFK - KIT, REPAIR, CATHETER, HEMODIALYSIS

NFM - EXPANDER, TISSUE, ORBITAL

NFN - GUIDEWIRE, CORONARY, TOTAL


OCCLUSION

Not
Classified

NGV - SYSTEM, APPENDAGE CLOSURE, LEFT


ATRIAL

Not
Classified

NHA - ABUTMENT, IMPLANT, DENTAL,


ENDOSSEOUS

NHC - CATHETER, VENTRICULAR (CONTAINING


ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

NHK - RESUSCITATOR,MANUAL,NON SELFINFLATING

NHR - MATERIAL, IMPLANT, UTERINE, FOR


ADHESIOGENIC EFFECT

Unclassified

NHW - ELECTRODE, PACING AND


CARDIOVERSION, TEMPORARY, EPICARDIAL

NIE - CATHETER, HEMODIALYSIS, TRIPLE LUMEN,


NON-IMPLANTED

NIX - HEARING AID, AIR CONDUCTION,


TRANSCUTANEOUS SYSTEM

NJA - ACCESSORY, SYSTEM, EXTERNAL FIXATOR,


CONTAINING ANTIMICROBIAL AGENT
NJC - CLIP, VAS DEFERENS

2
2

N
N

Y
Y

NJD - PROSTHESIS, KNEE, FEMOROTIBIAL, SEMICONSTRAINED,


UNICOMPARTMENTAL/UNICONDYLAR,
UNCEMENTED, POROUS-COATED,
METAL/POLYMER

NJU - SUTURE, NONABSORBABLE, NITINOL

19

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NKG - ORTHOSIS, CERVICAL PEDICLE SCREW


SPINAL FIXATION

Unclassified

NKH - ORTHOSIS, PEDICLE SCREW SPINAL


SYSTEM, SPONDYLOSIS AND FACET
DEGENERATION

Not
Classified

NKL - MOLECULAR ADSORBENT RECIRCULATING


SYSTEM (MARS)

Unclassified

NKM - MITRAL VALVE REPAIR DEVICES

Not
Classified

NMA - TUBE, TRACHEAL, REPROCESSED

NMJ - CLIP, IMPLANTABLE, REPROCESSED

NOL - REAGENTS, RNA AMPLIFICATION, SARS


CORONAVIRUS

Not
Classified

NOU - CONTINUOUS, VENTILATOR, HOME USE

NOV - ANCHOR, SUTURE, BONE FIXATION,


METALLIC

NOY - AGENTS, EMBOLIC, FOR TREATMENT OF


BENIGN HYPERPLASIA

Not
Classified

NPF - MONITOR, APNEA, HOME USE

NPJ - PROSTHESIS, KNEE


PATELLOFEMOROTIBIAL, PARTIAL, SEMICONSTRAINED, CEMENTED,
POLYMER/METAL/POLYMER

NPK - BARRIER, SYNTHETIC, INTRAORAL

NPL - BARRIER, ANIMAL SOURCE, INTRAORAL

NPM - BONE GRAFTING MATERIAL, ANIMAL


SOURCE

NPU - PROSTHESIS, MITRAL VALVE,


PERCUTANEOUSLY DELIVERED

Not
Classified

NQB - CONFORMER, OPHTHALMIC, BIOLOGICAL


TISSUE

NQH - SENSOR, PRESSURE, ANEURYSM,


IMPLANTABLE

20

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

NQJ - CATHETER, HEMODIALYSIS, NONIMPLANTED, ULTRAFILTRATION, FOR PERIPHERAL


USE

NQP - POSTERIOR METAL/POLYMER SPINAL


SYSTEM, FUSION

NQW - ORTHOSIS, SPINE, PLATE, LAMINOPLASTY,


METAL

NRO - SURGICAL LIP IMPLANT

2
Not
Classified

NRV - IMPLANTABLE RADIO FREQUENCY


TRANSPONDER SYSTEM

NUD - VERTEBROPLASTY COMPOUND, CALCIUM


BASED

NUN - BONE GRAFTING MATERIAL, HUMAN


SOURCE

NVH - SUTURE, KNOT, MECHANICAL

NVR - INTERVERTEBRAL FUSION DEVICE WITH


BONE GRAFT, SOLID-SPHERE, LUMBAR

Unclassified

NVU - AGENT, VASCULAR, EMBOLIZATION, DRUGELUTING

Not
Classified

NWA - PROSTHESIS, TRACHEAL,


PREFORMED/MOLDED

NWJ - SUTURE, RECOMBINANT TECHNOLOGY

NXP - STENT, TIBIAL

2
Not
Classified

NXW - STENT, TIBIAL, ABSORBABLE

Not
Classified

NYT - PROSTHESIS, TRACHEAL, EXPANDABLE,


POLYMERIC

NZT - DOSIMETER, IONIZING RADIATION,


IMPLANTED

OAT - IMPLANT, ENDOSSEOUS, ORTHODONTIC

OBL - CEMENT, BONE, PRE-FORMED, MODULAR,


POLYMERIC, VERTEBROPLASTY

NQY - VENTILATOR, CONTINUOUS, MINIMAL


VENTILATORY SUPPORT, HOME USE

NXM - PROSTHESIS, EYELID SPACER/GRAFT,


BIOLOGIC

21

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OBM - CEMENT, BONE, VERTEBROPLASTY, PREFORMED, MODULAR

OBT - PLATE, BONE, GROWTH CONTROL,


PEDIATRIC, EPIPHYSIODESIS

OCD - STIMULATOR, CERVICAL SPINAL CORD,


CEREBRAL VASOSPASM

Not
Classified

ODE - ENDOSCOPIC SUTURE/PLICATION SYSTEM,


GASTROESOPHAGEAL REFLUX DISEASE (GERD)

ODL - HYPERTENSION-THERAPY ELECTRICAL


NERVE STIMULATION SYSTEM

Not
Classified

ODM - NOCTURNAL DIALYSATE DELIVERY SYSTEM

Not
Classified

ODO - SORBENT REGENERATED NOCTURNAL


DIALYSATE DELIVERY SYSTEM

Not
Classified

ODP - INTERVERTEBRAL FUSION DEVICE WITH


BONE GRAFT, CERVICAL
ODU - FACIAL IMPLANT

2
2

N
N

Y
Y

OEW - TRACKING, SOFT TISSUE, INTRAOPERATIVE

OHA - HEART VALVE, MORE THAN MINIMALLY


MANIPULATED ALLOGRAFT

Unclassified

OIS - CALCIUM SALT BONE VOID FILLER,


DRILLABLE, NON-SCREW AUGMENTATION

OIY - PROSTHESIS, KNEE,


PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
CEMENTED, POLYMER +
ADDITIVE/METAL/POLYMER + ADDITIVE

OJB - RESORBABLE SPINAL INTERVERTEBRAL


BODY FIXATION ORTHOSIS - PLATE

OJM - RESORBABLE SPINAL INTERVERTEBRAL


BODY FIXATION ORTHOSIS - MESH

22

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OKC - IMPLANTED SUBCUTANEOUS SECUREMENT


CATHETER

OKS - LACRIMAL STENTS AND INTUBATION SETS

Unclassified

OLB - DRUG-ELUTING INTERNAL PUDENDAL


ARTERY (IPA) AND HYPOGASTRIC ARTERY STENT

Not
Classified

OLC - SCAFFOLD, PARTIAL MEDIAL MENISCAL


DEFECTS EXTENDING INTO THE RED/WHITE
ZONE, RESORBABLE BOVINE COLLAGEN

OLL - SEPTAL STAPLER/ABSORBABLE STAPLES

OMF - PERCUTANEOUS, IMPLANTED, LONG-TERM


INTRAVASCULAR CATHETER ACCESSORY FOR
CATHETER POSITION

OMH - PERICARDIAL PATCH TO FACILITATE


REVISION SURGERIES
OMR - VESSEL GUARD OR COVER
OOD - SURGICAL FILM

2
2
2

Y
N
Y

Y
Y
Y

OOM - SUBTALAR JOINT-CROSSING UNCEMENTED


SEMI-CONSTRAINED ANKLE PROSTHESIS

Not
Classified

OPZ - PROSTHESIS, SHOULDER, NONTRADITIONAL STEM, SEMI-CONSTRAINED,


METAL/POLYMER, UNCEMENTED

OQG - HIP PROSTHESIS, SEMI-CONSTRAINED,


CEMENTED, METAL/POLYMER, + ADDITIVE,
POROUS, UNCEMENTED

OQH - HIP, SEMI-CONSTRAINED, CEMENTED,


METAL/POLYMER + ADDITIVE, CEMENTED

OQI - HIP, SEMI-CONSTRAINED, CEMENTED,


METAL/CERAMIC/POLYMER + ADDITIVE, POROUS
UNCEMENTED

ORY - PRELUDE TONGUE SUSPENSION SYSTEM

OSH - PEDICLE SCREW SPINAL SYSTEM,


ADOLESCENT IDIOPATHIC SCOLIOSIS

23

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OSN - SOFTWARE FOR DIAGNOSIS/TREATMENT

OSO - IN-SITU, POLYMER, BONE FIXATION

Not
Classified

OST - IN UTERO FETAL TRACHEAL OCCLUSION


DEVICE, DETACHABLE BALLOON AND DELIVERY
SYSTEM

Not
Classified

OTD - ENDOVASCULAR SUTURING SYSTEM

OTM - MESH, SURGICAL, FOR STRESS URINARY


INCONTINENCE, MALE

OTN - MESH, SURGICAL, SYNTHETIC,


UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, MULTI-INCISION

OTO - MESH, SURGICAL, SYNTHETIC,


UROGYNECOLOGIC, FOR APICAL VAGINAL AND
UTERINE PROLAPSE, TRANSABDOMINALLY
PLACED

OTP - MESH, SURGICAL, SYNTHETIC,


UROGYNECOLOGIC, FOR PELVIC ORGAN
PROLAPSE, TRANSVAGINALLY PLACED
OUR - SACROILIAC JOINT FIXATION

2
2

N
N

Y
Y

OVD - INTERVERTEBRAL FUSION DEVICE WITH


INTEGRATED FIXATION, LUMBAR

OVE - INTERVERTEBRAL FUSION DEVICE WITH


INTEGRATED FIXATION, CERVICAL

OVZ - PIN, FIXATION, RESORBABLE, HARD TISSUE

OWI - BONE FIXATION CERCLAGE, SUBLAMINAR

OWR - MESH, SURGICAL, NON-ABSORBABLE,


FACIAL IMPLANTS FOR PLASTIC SURGERY

OWS - MESH, SURGICAL, COLLAGEN, PLASTICS,


FACIAL IMPLANTS

OWT - MESH, SURGICAL, ABSORBABLE,


ABDOMINAL HERNIA

24

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OWU - MESH, SURGICAL, NON-ABSORBABLE,


DIAPHRAGMATIC HERNIA

OWV - MESH, SURGICAL, COLLAGEN,


DIAPHRAGMATIC HERNIA

OWW - MESH, SURGICAL, ABSORBABLE,


ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWX - MESH, SURGICAL, NON-ABSORBABLE,


ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWY - MESH, SURGICAL, COLLAGEN,


ORTHOPAEDICS, REINFORCEMENT OF TENDON

OWZ - MESH, SURGICAL, ABSORBABLE,


THORACIC, CHEST WALL RECONSTRUCTION

OXA - MESH, SURGICAL, NON-ABSORBABLE,


THORACIC, CHEST WALL RECONSTRUCTION

OXB - MESH, SURGICAL, COLLAGEN, THORACIC,


CHEST WALL RECONSTRUCTION

OXC - MESH, SURGICAL, ABSORBABLE, STAPLE


LINE REINFORCEMENT

OXD - MESH, SURGICAL, NON-ABSORBABLE,


STAPLE LINE REINFORCEMENT

OXE - MESH, SURGICAL, COLLAGEN, STAPLE LINE


REINFORCEMENT

OXF - MESH, SURGICAL, ABSORBABLE, PLASTIC


AND RECONSTRUCTIVE SURGERY

OXG - MESH, SURGICAL, NON-ABSORBABLE,


PLASTIC AND RECONSTRUCTIVE SURGERY

OXH - MESH, SURGICAL, COLLAGEN, PLASTIC AND


RECONSTRUCTIVE SURGERY

OXI - MESH, SURGICAL, ABSORBABLE, LARGE


ABDOMINAL WALL DEFECTS

25

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

OXJ - MESH, SURGICAL, NON-ABSORBABLE,


LARGE ABDOMINAL WALL DEFECTS

OXK - MESH, SURGICAL, COLLAGEN, LARGE


ABDOMINAL WALL DEFECTS

OXL - MESH, SURGICAL, ABSORBABLE, ORGAN


SUPPORT

OXM - MESH, SURGICAL, ABSORBABLE, FISTULA

OXN - MESH, SURGICAL, COLLAGEN, FISTULA

OYR - FILLER, BONE VOID, RECOMBINANT


PLATELET-DERIVED GROWTH FACTOR

Not
Classified

OZI - INTERNAL HINGED ELBOW FIXATOR

Not
Classified

OZS - PRESSURE, FLUID REMOVAL, FASCIOTOMY,


INTRACOMPARTMENTAL

Not
Classified

PAG - MESH, SURGICAL, NON-SYNTHETIC,


UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, MULTI-INCISION

PAH - MESH, SURGICAL, SYNTHETIC,


UROGYNECOLOGIC, FOR STRESS URINARY
INCONTINENCE, FEMALE, SINGLE-INCISION MINISLING

PAI - MESH, SURGICAL, NON-SYNTHETIC,


UROGYNECOLOGIC, FOR PELVIC ORGAN
PROLAPSE, TRANSVAGINALLY PLACED

PAJ - MESH, SURGICAL, NON-SYNTHETIC,


UROGYNECOLOGIC, FOR APICAL VAGINAL AND
UTERINE PROLAPSE, TRANSABDOMINALLY
PLACED

PAO - PROSTHESIS, SHOULDER, SEMICONSTRAINED, METAL/POLYMER + ADDITIVE,


CEMENTED

26

List of Medical Devices, by Product Code,


that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices
for purposes of Section 614 of FDASIA
amending Section 519(f) of the FDC Act November 2012

Product Code - Preferred Name

Device
Regulatory
Class

Life
Saving or
Sustaining
Devices

Implantable
Devices

PAW - NONABSORBABLE EXPANDED


POLYTETRAFLUOROETHYLENE SURGICAL
SUTURE FOR CHORDAE TENDINAE REPAIR OR
REPLACEMENT

PBI - PROSTHESIS, HIP, CONSTRAINED,


CEMENTED OR UNCEMENTED, METAL/POLYMER,
+ ADDITIVE

PBJ - CRANIAL DISTRACTION SYSTEM

PBQ - FIXATION, NON-ABSORBABLE, FOR PELVIC


USE

PBU - BONE VOID FILLER, SYRINGE

Not
Classified

27

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