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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS028
Date Received05/11/2001
Decision Date04/29/2002
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
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