Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY GENERATORS, LEADS PROGRAMING SOFTWARE, PROGRAMMING WAND AND ASSCCESORY PACK

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Praxis Extended RAS Panel

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF IMPLANTABLE SPINAL FUSION STIMULATORS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT TRANSJUGULAR PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LV LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS