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 | ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS |
Generic Name | CATHETER, FLOW DIRECTED |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S213 |
Date Received | 09/27/2002 |
Decision Date | 10/23/2002 |
Reclassified Date
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10/08/2010 |
Product Codes |
DYG LOX MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS. |
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