Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter,

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT PY-60AD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER AND THERMOCOOL CATHETER FAMILIES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL & SYNERGY EZ PATIENT PROGRAMMER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-SITE LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISERT MODEL PC-60AD PACKAGING IMPROVEMENT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·NUVISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT