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 | NIR PRIMO PREMOUNTED STENT SYSTEM |
Applicant | Boston Scientific Corp. One Boston Scientific Place Natick, MA 01760 |
PMA Number | P980001 |
Supplement Number | S001 |
Date Received | 08/25/1998 |
Decision Date | 05/20/1999 |
Withdrawal Date
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08/13/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the NIR Primo Premounted Stent System. |
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