Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE LEADS AND ACCESSORIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK LEADS AND ACCESSORIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SELUTE LEADS AND ACCESSORIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEETIP RX/SWEET PICOTIP RX/FLEXTEND

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK P2 LEADS AND ACCESSORIES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DUETT SEALING DEVICE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

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

FDA Pre-Market Approval

FDA Class 3 ·Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDOVASCULAR SOLUTIONS ANCURE ENDOGRAFT SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System 3mL & 5mL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEPP BRAIN STIMULATION ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS