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 | EXPRESS 2 MR & OTW CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P020009 |
Supplement Number | S028 |
Date Received | 08/31/2006 |
Decision Date | 09/21/2006 |
Withdrawal Date
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12/06/2018 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE METHOD FOR REMOVAL O THE DISTAL HEAT SHRINK MANUFACTURING AID OF THE DEVICE. |
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