Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z/CAPSURE Z/SP NOVUS & VITATRON IMPULSE & IMPLUSE II & VIATRON EXCELLENCE SS +

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4; Visia AF MRI VR ICD DVFB1D4, DVFC3D4; Visia AF VR ICD DVAB1D1, DVAB1D4

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·INTELLAGEN™ Cardiac Ablation System

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA FAMILY/C-SERIES/T-SERIES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA THERAPY FOR DBS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Wallstent Illiac Endoprosthesis with unistep plus delivery system

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ZOOM LATITUDE PROGRAMMING SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II & THINLINE II

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD ILLIAC PREMOUNTED STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System (Monrail and Over-The-Wire)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE/PROGRAMMER/RECORDER/MONITOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EPICARDIAL PATCH LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SVC/CS TRANSVENE LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD CRT-D; CLARIA MRI CRT-D & QUAD CRT-D; COMPIA MRI CRT-D & QUAD CRT-D ;