Stent, Coronary

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE MONORAIL & OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM OVER THE WIRE (OTW)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P,SYNCRA CRT-P

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR

Stent, Coronary

FDA Pre-Market Approval

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Corox (ProMRI0 OTW,75,85,S75,L75,LB85 BP; Sentus (ProMRI) OTW,75,85,S75,S85,L75,L85,QP S75S85,S95,l75,l85,L95,S75/49,S75

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL (MR) & OVER-THE-WIRE (OTW) CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Over-the-Wire (OTW) Zotarolimus Eluting Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL AND MAVERICK OTW PTCA CATHETER, QUANTUM MAVERICK PTCA CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193