Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT, ENDURANT II, ENDURANT II AORTO -UNI-ILIAC (AUI) AND ENDURANT II'S STENT GRAFT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat/INSTAT Absorbable Collagen Hemostatic Agent

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/ACTIVA PC & RC

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Siello, Solia, Setrox, and Safio

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS Vascular Stent

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Viabhan Endoprosthesis and endoprosthesis with Heparin Bioactive Surface

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF THE ITREL 4, RESTORE, & SURE SCAN MRI FAMILIES OF IMPLANTABLE SPINAL CORD STIMULATORS