Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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

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

Stent, Coronary

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

FDA 510(k)

FDA Class 3 ·Cardiovascular