Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Pulmonx Zephyr Endobronchial Valve (EBV)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Insulin Pump

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval

FDA Class 3 ·SLEEP SENTRY

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP Flex with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK GEMNOS 04, 04A, AND TC 04

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis without InhibiZone™

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA TREMOR CONTROL THERAPY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD