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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, MN 55311
PMA NumberP970061
Supplement NumberS003
Date Received08/19/1998
Decision Date09/15/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at scimed life systems, one scimed place, maple grove, minnesota.
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