Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG; Attesta SR MRI IPG; Relia IPG; Sphera SR MRI IPG

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR/S VR,XT DR, XT VR ICD; ENTRUST; INTRINSIC 30 & INTRINSIC ICD; MARQUIS DR, VR ICD; MAXIMO DR, II, VR ICD; PROT

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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MARQUIS ICD/MAXIMO/MAXIMO II/INTRINSIC/ENTRUST/VIRTUOSO/SECURA ICD FAMILIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN™ ICD Models D150, D151, D152, D153; INOGEN™ ICD Models D140,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Autogen, Dynagen, Inogen, Origen NG3 ICDs; Resonate, Vigilant, Perciva NG4 ICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Cardiac Defibrillators, Emblem™ MRI S-ICD, Emblem™ S-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK LEADS/ACUITY LEADS/CONTAK RENEWAL PG/LIVIAN ICD/COGNIS ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A219

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN EL ICD'S AND DYNAGEN, INOGEN, ORIGEN MINI ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q and RES-Q MICRON ICD and ICD Lead Family

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D