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 | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S006 |
Date Received | 11/23/1998 |
Decision Date | 06/30/1999 |
Withdrawal Date
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07/17/2007 |
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 31 mm SCIMED(R) RADIUS(TM) Coronary Stent with Over-The-Wire (OTW) and Single-Operator (SOE) Delivery Systems. |
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