System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAAADVANTAGE STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P INSYNC, INSYNC III, SYNCRA CRT-P AND CONCERTO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPRSTHESIS, MODEL 6625LP AND 6625-ESR-LP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM/VITALITY

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL CATHETER FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·FINISHING WIRE UNIVERSAL

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

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC HF SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT DR RF,ACCENT SR RF PACEMAKER DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-D Resynchronization Devices

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE, GORE VIABAHN ENDOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/C & T SERIES IPGS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS II DR-T