Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST OPTIM LEADS MODELS 7020, 7021,7022,7030,7031,7070 AND 7071

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protecta ICD, Protecta VR ICD, ProtectaXT ICD, Secura DR ICD, Secura ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/VIRTUOSO/MAXIMO II/SECURA/MARQUIS/MAXIMO/INTRINSIC 35J/30/VIRTUOSO II ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ORIGEN EL ICD: D050, D051, D052, D053 INOGEN EL ICD: D140, D141, D142,

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·KONECT RESILIA Aortic Valved Conduit (AVC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST,SECURA,GEM II/III VR/DR,INTRINSIC/INTRINSIC 30,MAXIMO VR/DR,MAXIMO II,MARQUIS VR/DR,PROTECTA/PROTECTA XT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·KONECT RESILIA Aortic Valved Conduit (AVC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FR3 Defibrillator

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S D DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series and Propaq MD

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV ICD, Epsila EV Extravascular Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTOUR(R) II/ANGSTROM(TM) II ICD SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA DF4 ICD, PROTECTA ICD, PROTECTA XT DF4 ICD, PROTECTA XT ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve