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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 PREMOUNTED STENT DELIVERY SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS027
Date Received12/01/2000
Decision Date12/27/2000
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of the creep test for assessing package seal integrity.
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