Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse, Kappa

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·End Cap and Upsizing Sleeve

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

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