Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS
- PMA Number
- P970035
- Supplement Number
- S028
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 29, 2002
- Date Received
- May 11, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE THUNDER HIGH SCAFFOLDING OVER-THE-WIRE (OTW) AND RAPID EXCHANGE (RX) SAPHENOUS VEIN GRAFT (SVG) STENT SYSTEMS; THE ADDITION OF A NEW MANUFACTURING FACILITY, AVE IRELAND LIMITED, GALWAY, IRELAND; AND THE ADDITION OF A NEW CONTRACT STERILIZER, IOTRON EBIS INDUSTRIES UK, LTD., OXFORDSHIRE, UNITED KINGDOM. THE DEVICES, WILL BE MARKETED UNDER THE TRADE NAMES OF THE THUNDER HIGH SCAFFOLDING OTW AND RX SVG STENT SYSTEMS, AND ARE INDICATED FOR IMPROVING VESSEL LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO LESIONS (LENGTH <= 40 MM) IN SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS BETWEEN 3.0 MM AND 5.0 MM. LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. THE RX DELIVERY SYSTEM WILL ALLOW FOR PERFUSION AT AN AVERAGE RATE OF 2 CC/MIN AT NOMINAL PRESSURE DURING THE 15-30 SECOND STENT DEPLOYMENT PROCEDURE ONLY. THE RAPID EXCHANGE STENT DELIVERY SYSTEM IS NOT INTENDED FOR USE AS A STAND ALONE PTCA PERFUSION CATHETER.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |