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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Coro

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA IMPLANTABLE NEUROSTIMULATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC3/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM and Medtronic CoreValve Evolut R System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO, PROPONENT, ACCOLADE PACEMAKER

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRIME FAMILIES OF IMPLANTABLE NEUROSTIMULATOR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAGLIDE(TM) LUBRICANT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM II MODEL 3058 NEUROSTIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM