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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.
 
Trade NameBOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP970061
Supplement NumberS009
Date Received07/17/2000
Decision Date08/22/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing facility located at boston scientific/scimed, inc. , plymouth, minnesota 55442 and an additional sterilization facility located at iba, willowbrook, illinois 60521.
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