Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL(R) 3 SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Annular Closure Device

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device

Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Annular Closure Device

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ID/SN Label

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL AND

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS