Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System (2-Lead configuration)

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval

FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/ FLEXITIP XL-R

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

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

FDA Pre-Market Approval

FDA Class 3 ·MemoryGel Silicone Gel-Filled Breast Implants

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·Raindrop Near Vision Inlay

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY PERENNIAFLEX

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 1256D META MV CARDIAC PULSE GENERATOR