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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 SYSTEM
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980001
Supplement NumberS003
Date Received01/19/1999
Decision Date02/25/1999
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
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