Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 Connector Port Pin Plug Kit, Sprint Quattro 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 ·ACE HEADER/TRANSVENE DEFIBRILLATION LEAD/LEAD END PIN CAP/UPSIZING SLEEVE

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

FDA Pre-Market Approval

FDA Class 3 ·Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD END PIN, ACTIVE CAN EMULATOR HEADER, SIZING & UPSIZING SLEEVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE) ACE/ACE 5434T/ACE HEADER/LEAD END PIN CAP

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, HV Splitter/Adopter Kit, Sprint Quattro Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface