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 | RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S012 |
Date Received | 10/09/2001 |
Decision Date | 11/29/2001 |
Withdrawal Date
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07/17/2007 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD, GALWAY, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND. |
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