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 | VOYAGER NC CORONARY DILATATION CATHETER |
Generic Name | STENT, CORONARY |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S232 |
Date Received | 12/09/2009 |
Decision Date | 02/04/2010 |
Reclassified Date
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10/08/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER. |
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