Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM,DERMA PLATFORM

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC ICD 7272

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC IPG 8040

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM MODEL 7227 CX/B/D/E

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT 7276

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

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

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)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLBELLA XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvederm Injectable Gel Implants

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL SYSTEMS

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST