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 | TAXUS EXPRESS2 STENT DELIVERY SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S012 |
Date Received | 11/05/2004 |
Decision Date | 11/30/2004 |
Withdrawal Date
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12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADDITION OF AN ALTERNATIVE SUPPLIER OF STAINLESS STEEL USED IN THE MANUFACTURE OF STENT COMPONENTS. |
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