Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EnTrust, Gem,Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4 Prote

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P,SYNCRA CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICD'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT DR, Astra S DR, Astra S SR, Astra XT SR MIR IPG and Azure S DR, Azure S SR, Azure XT DR, Azure XT SR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR IC

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG & CapSureFix MRI SureScan Lead MRI

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG,ADVISA DR MRI IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE, CAPSURE SP, CAPSURE SP NOVUS, CAPSURE SENSE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5423 ECG CABLE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI, ENPULSE, KAPPA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA,SENSIA IPG,ADVISA (DR/DR MRI) IPGS,ENRHYTHM MRI,ENPULSE (E1/E2) IPG,KAPPA D(700/900) IPG,KAPPA DR(650) IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG