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

FDA Pre-Market Approval

FDA Class 3 ·Interface Cable for Multi-Electrode Ablation Catheters (nMARQ)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT FOR USE IN PERIPHERAL VASCULAR SUR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Totally Implanted Spinal Cord Stimulator for Pain Relief

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT CONTACT LENS FOR EXTEND WEAR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 370-08 WAND EXTENSION FOR COSMOS(R)RX2000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3038 FUNCTION PACK FOR APS-II 3003 PROGRAMME

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaPlug®, Absorbable Collagen Wound Dressing for Dental Surgery

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

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE(1503.U) FOR ICS 3000/RENAMIC PROGRAMMERS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric