Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16,

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

FDA Pre-Market Approval

FDA Class 3 ·INTENSIA CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK(R) LEAD SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant, Endurant II, and Endurant IIs Stent Graft System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV OPEN-IRRIGATED ABLATION CATHETER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·VITATRON CRYSTALLINE LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD; S VR ICD; EVERA XT DR ICD; XT VR ICD; MAXIMO II ICD; PROTECTA ICD; XT ICD; SECURA ICD; VIRTUOSO II DR/VR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Sierra Everolimus Eluting Coronary Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER Muscular VSD Occluder

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, SF Bi-Directional Navigation

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA; MAXIMO II; & VARIOUS FAMILIES OF CONCERTO, INSYNC, & PROTECTA