System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Viabhan Endoprosthesis and endoprosthesis with Heparin Bioactive Surface

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL ELUTING STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP; Blazer Prime XP

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·350 SERIES/ADAPTOR/AT500/ENPULSE/ENRHYTHM/KAPPA 600/650/700/800/900/RELIA/SENSIA/VERSA/SIGMA/PATIENT ACTIVATOR

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1703.U

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

FDA Pre-Market Approval

FDA Class 3 ·PSW 1901.U

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)