Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK INSTRUMENT COMMAND LIBRARY, MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR.

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Drug Delivery Infusion Pumps SynchroMed

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP Vascular Closure Device, MYNX CONTROL Vascular Closure Device

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators