Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, AND TELIGEN, PUNCTUA, ENERGEN, AND INCEPTA ICD FAMILIES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

FDA Pre-Market Approval

INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DS

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Visia AF Application Software, CareLink SmartSync Evera MRI Application Software, Cobalt MRI ICD, Cob

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD) - Origen: D000, D001, D002, D003, D050, D051, D052, D053 - Inogen: D010, D0

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

FDA Pre-Market Approval

FDA Class 3 ·Contak CD, Contak Renewal, Livian ICD Families; EasyTrak, Acuity Spiral Lead Families; Cognis, Energen, Incepta, Origen,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC30/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS

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