Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT)

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·INTERTACH(R)II MODELS 262-16

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EPG-SINGLE AND DUAL CHAMBER

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK AND RENEWAL FAMILIES

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ASCENDA INTRATHECAL CATHETERS AND KITS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+ C & T SERIES IPGS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RENEWAL 3 RF ICDS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Express® LD Iliac Premounted Stent System

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Visi-Pro™ Balloon-expandable Peripheral Stent System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myopore® Sutureless Myocardial Pacing Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWWAL TR INVIVE FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Devices TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD