Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus-Eluting Coronary Stent Systems, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET TM AND ACS MULTI-LINK OTW DUET TM CORONARY STENT SYSTEMS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS(R) DURAFLEX(TM) LOW PRESSURE BIOPROSTHESIS, MODEL 6625-LP AND 6625-ESR-LP(BOTH MITRAL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System – RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON MINI IPG NEUROSTIMULATION SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OTW & MULTI-EXCHANGE II (MX2) & RAPID EXCHANGE (RX) DELIVERY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM