Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·AngelMed Guardian System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV TEST

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

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

FDA Pre-Market Approval

FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Mitral Bioprosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Prestige LP Cervical Disc

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEL BREAST IMPLANT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·GENESEARCH BREAST LYMPH NODE ASSAY

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·NOVOCURE NOVOTTF-100A SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM