Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MONORAIL AND OVER-THE-WIRE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LEAD ANCHORING SLEEVE KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV DDD/AV II DDDD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1D4,Evera MRI S DR SureScan Model DDMC3D4, Ev

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODEL 2490C, MODEL 24950; CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MODEL 2491 DD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+/CAPSURE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Pro Cryoballoon Catheter

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD, 4665, 4968

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT LLIAC ENDOPROSTHESIS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION (DBS)

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·IGM ENZYME IMMUNOASSAY

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM