Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis with and without InhibiZone Treatment

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Medstream Programmable Infusion System

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM PLUS (HYLAN B GEL)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETERIAL ABALTION SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·ThinPrep 5000 Processor

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM