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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.
 
DeviceS7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N
Generic NameSTENT, CORONARY
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP970035
Supplement NumberS038
Date Received04/23/2002
Decision Date10/15/2002
Withdrawal Date 10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING TRADE NAMES AND EXPANDED DEVICE INDICATIONS: THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT." THE S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT." THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS (LENGTH <=30 MM) IN NATIVE CORONARY ARTERIES AND SAPHEOUS VEIN GRAFTS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM THROUGH DIRECT STENTING OR PREDILATATION. LONG-TERM OUTCOME (BEYOND 180 DAYS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. THE RAPID EXCHANGE 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." THE S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV100 BALLOON IS INDICATED FOR: "IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH...
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