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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE AT 6F & PROGLIDE SUTURE-MEDICATED CLOSURE SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Insulin Pump

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Mentor Memoryshape, Breast Implants

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus Eluting Coronary Stent System / Resolute Onyx OTW Zotarolimus Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Quickflex µ, Quartet

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE CURRENT FAMILY OF ICD'S

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

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST