Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2020A CARDIOSIGHT READER AND THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Maximo II ICD, Protecta ICD, Protecta VR ICD, Protecta XT ICD, Secura DR ICD, Secura ICD, Virtuoso II DR/VR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epsila EV Extravascular Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

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,

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

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

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

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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