Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL, INOGEN EL, DYNAGEN EL NG3 ICD;ORIGEN MINI, INOGEN MINI, DYNAGEN MINI NG2.5 ICD; INCEPTA, ENERGEN, PUNCTUA PRO

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL CI System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED EL PROGRAMMABLE PUMP

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL CONCERT IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implants

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

FDA Pre-Market Approval

FDA Class 3 ·PG VALITUDE CRT-P IS1 EL US, PG VALITUDE CRT-P IS4 EL US, PG VISIONIST CRT-P IS1 EL US, PG VISIONIST CRT-P LV1 EL US, PG

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED PUMP AND INFUSION SYSTEM (SYNCHROMED EL AND SYNCHROMED II)

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILIES OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN™ EL ICD: D150, D151, D152, D153; INOGEN™ EL ICD: D140, D141, D142, D143; ORIGEN™ EL ICD: D050, D051, D052, D053;

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL ICD & MINI ICD, INOGEN EL ICD & MINI ICD; DYNAGEN EL ICD & MINI ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN ™ EL ICD: D050, D051, D052, D053; INOGEN ™ EL ICD: D140, D141, D142, D143; DYNAGEN ™ EL ICD: D150, D151, D152, D1

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

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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