Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED IMPLANTABLE INFUSION SYSTEM FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(TM) COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY 55 UV (METHAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Energys (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES