Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CPI MODEL 6826 & 6828 AICD LEAD STYLET

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·FLUORO-CEP (R) PROGESTERONE

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM