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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 NameNIR(TM) PREMOUNTED STENT SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS026
Date Received10/11/2000
Decision Date11/08/2000
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing change to include the use of scrapped material in final functional testing to obtain trending data for sox securement.
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