Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935 (DF-1), SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947 (DF-1)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT

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

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve Kit

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

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Llivia, Inlexa, Intica 7/5, VR-T/ DR-T DF4

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD; Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD;

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, Evera MRI ICD's; Mirro MIR DR, Mirro MIR VR ICD's; Primo MRI DR, Primo MRI VR ICD's; Visia AF MRI DF1, V

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1/DF-1 LEAD AND RELIANCE 4-SITE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PIN PLUG, DF-1 Y-ADAPTER/ EXTENDER, LEAD ASSEMBLY SILICONE DEFIBRILLATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS

FIRST MEDIC MODE 610

FDA 510(k)

FDA Class 3 ·Cardiovascular