Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE WITH GLIDE TECHNOLOGY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI & CONTAK RENEWAL 3

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE CRT-P, INTUA CRT-P, VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P, and Programmer Softwa

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRx and VENTAK MINI

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX/SWEET PICOTIP RX/FLEXTEND FAMILIES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY, PRIZM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VISIONIST Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLogic™

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER MODELS. ESSENTIO , PROPONENT, ACCOLADE MRI'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S /GS /G

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Duct Occluder/Amplatzer Duct Occluder II