Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG / DR MRI IPG/ SR MRI IPG; Astra XT DR MRI IPG / S DR MRI IPG / S SR MRI IPG/ XT SR MRI IPG; AZURA S DR MRI

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Vitatron Crystalline Lead and Vitatron Excellence + Lead

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Atherectomy System

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor Heart Valve

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT-

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE, ENDOTAK RELIANCE 4-SITE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE DEFIBRILLATOR LEAD

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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