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 | CORONARY DILATATION CATHETERS |
Generic Name | STENT, CORONARY |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S220 |
Date Received | 11/06/2006 |
Decision Date | 12/11/2006 |
Reclassified Date
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10/08/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO. |
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