Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx (RX), Resolute Onyx (OTW), Resolute Onyx (RX) (2.0mm), Resolute Onyx (OTW) (2.0mm), Onyx Frontier RX Zotar

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW STEROID LV LEAD MONITORING (COSMO)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System RX and OTW

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS MR & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY RX & OTW CORONARY STENT SYSTEMS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System Rx and OTW

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM