Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK OTW ULTRA & MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX AND OTW VISION AND MINI VISION CORONARY STENT SYSTEMS

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTOME CUTTING BALLOON MONORAIL (MR) AND OVER-THE-WIRE (OTW) PTCA CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

OMC NI MEDICAL LIMITED

Importer

1 Manufacturer

Etiometry Platform Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Etiometry Inc.·1 device

Stent, Coronary

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8