Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL Fish Probe Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·VYSIS CLL FISH PROBE KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALL NON-RATE RESPONSIVE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ALL RATE RESPONSIVE IMPLANTABLE PACEMAKERS

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·All Flex 4-Socket Hi-POT/Pulse Test System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS)

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path Ablation Catheter (including all braid catheter)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION/MULTI-LINK 8 LL/SV CORONARY STENT SYSTEMS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System