Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO-DRIVER CORONARY STENT SYSTEM (MX2 & OTW)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·AATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW/ATTAIN LV LEAD/ATTAIN CS LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX LIBERTE MONORAIL & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEMS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx RX and OTW Coronary Stent Systems

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD

Stent, Coronary

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead,Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B