Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs / Elecsys HBs II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REALIANCE 4-SITE Family of Defibrillation Leads

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·ASCENSION MCP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata and Optisure

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE Header, Defibrillation Support Device (DISD), End Cap, Epicardial Patch Lead, Upsizing Sleeve

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD