Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Saline-Filled and Spectrum Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Natrelle Saline Filled Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO ICDS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC/INSYNC III CRT-IPGS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·TruSight Oncology Comprehensive

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM FAMILY OF ICDS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·PERLANE L INJACTABLE GEL

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT STENT GRAFT SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS, JUVEDERN VOLUMA XC