Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000 IMPLANT CONTROL SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.

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

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