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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.
 
DeviceMICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP030009
Supplement NumberS020
Date Received03/31/2008
Decision Date10/22/2008
Withdrawal Date04/02/2026
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE MICRO-DRIVER RAPID EXCHANGE DELIVERY PLATFORMAND THE ADDITION OF THE MEDTRONIC MEXICO FACILITY IN TIJUANA FOR THE MANUFACTURING OF CATHETERSUB-ASSEMBLIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MICRO-DRIVERRAPID EXCHANGE (RX) CORONARY STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.25 - 2.75 MM AND <= 21 MM IN LENGTH. OUTCOME BEYOND 270 DAYS FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
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