Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR (FAST)

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR