Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF LEADS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NOVA(TM) PULSE GENERATOR 7 RX 2000(TM) PROGRAMMER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTACK RENEWAL IS1/DR1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 RX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4)

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR AND ACCESSORIES/INTERFACE CABLE

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR RMT; NAVISTAR RMT DS CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar EP, EZ Steer Nav Bi-Directional

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS AND CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER