Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Terminal Pin Weld Process Monitoring Plan

Implant, Cochlear

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6725 IS-1 PIN PLUG

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL CONCERT (PIN) Cochlear Implant

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ LEAD END PIN CAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENCE CS/SVC LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/PATCH LEAD/LEAD END PIN CAP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, IS-1 COnnector Port Pin Plug Kit, Springt Quattro Lead, Subcutaneous Lead, and Transvene C

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CIONNECTIR PORT PIN PLUG, LEAD ADAPTOR, SPRINT QUATTRO LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO