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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 PRIMO PREMOUNTED STENT SYSTEM
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980001
Supplement NumberS001
Date Received08/25/1998
Decision Date05/20/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the nir primo premounted stent system.
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