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 SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Supplement Number | S005 |
Date Received | 09/08/1998 |
Decision Date | 02/11/1999 |
Withdrawal Date
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07/17/2007 |
Docket Number | N |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED(R) RADIUS(TM) Stent. The device, as modified, will be marketed under the trade name SCIMED(R) RADUS(TM) Coronary Stent with Single-Operator Exchange (SOE) Delivery System and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diameter ranging from 2.75 to 4.25mm and is intended to improve coronary luminal diameter. |
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