Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 6925

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II/PROTECTA/PROTECTA VR/PROTECTA XT/SECURA DR/SECURA/VIRTUOSO II DR/VR ICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Ellipse, Promote+

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·End Cap, Epicardial Patch Lead, Upsizing Sleeve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN™ MINI ICD VR, ORIGEN MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN MINI ICD

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN® Ultrasound Bone Healing System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD PG models A209 and A219.

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 S DR ICD, Evera S VR ICD, Evera XT DR ICD,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·D010 INOGEN™ MINI ICD VR; D011 INOGEN™ MINI ICD VR; D012 INOGEN™ MINI ICD DR; D013 INOGEN™ MINI ICD DR; D020 DYNAGEN™ MI

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALUED CONDUIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MICRO JEWEL/JEWEL II

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, Eve

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 DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M