Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED ARTERIAL CANNULA

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cervista HPV HR Assay

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Codman OR Prep Kits

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·CraniSeal Dural Sealant

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH 3.5F SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP PROCESSORS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER S, STINGER M, STINGER SM ABLATION CATHETERS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Implantable Penile Prosthesis

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System