Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT RP ENDOPROSTHESIS AND WALLSTENT ENDOPROTHESIS (TIPS)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EVIA/ENTOVIS/ECURO/EFFECTA/ESTELLA PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D and Compia MRI Quad C

Stent, Coronary

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG; ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARELINK HOME MONITOR MODEL 2491

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S ICD SYSTEM