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. |
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Device | MICRO-DRIVER RAPID EXCHANGE (RX) CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S020 |
Date Received | 03/31/2008 |
Decision Date | 10/22/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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