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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceSCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, MN 55311
PMA NumberP970061
Supplement NumberS005
Date Received09/08/1998
Decision Date02/11/1999
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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