Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter (AUS)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Atherectomy System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac Ablation Catheter and Cable

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Temperature Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Elemen Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent S

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS Systems)

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Spectrum Saline Breast Implants

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM