Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S660TM WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·HIGH FREQUENCY VENTILATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ BALLON-EXPANABLE STENT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIC TARGIS SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Durasphere Injectable Bulking Agent

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC AVE S660 ZIPPER MX CORONARY STENT SYSTEM AND S7 CORONARY STENT WITH ZIPPER DELIVERY SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System