Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS BOWEL PROGRAMMING SYSTEMS, N VISION PROGRAMMER

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM II INS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Reshape Integrated Dual Balloon System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·URYX URETHRAL BULKING AGENT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (Urinary)

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR PHOTOPHORESIS SYSTEM

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS Ambicor Inflatable Penile Prosthesis

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM PATIENT PROGRAMMER

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

FDA Pre-Market Approval

FDA Class 3 ·RECTAL THERMOSENSING UNIT RTU

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(R) ENDOPROSTHESIS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM II NEUROSTIMULATORS

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIC TARGIS SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM