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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 DELIVERY SYSTEM
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, MN 55311
PMA NumberP970061
Supplement NumberS001
Date Received08/10/1998
Decision Date02/04/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification ot the indications statement to include the treatment of saphenous vein graft lesions. The SCIMED RADIUS(TM) Coronary Stent (14 mm and 20 mm lengths) with Delivery System is indicated for use in patients with symptomaitc ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diamter ranging from 2.75 to 4.25 mm and is intended to improve coronary luminial diameter.
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