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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 NumberS008
Date Received05/10/1999
Decision Date06/11/1999
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the specification of the balloon component for the nir(tm) primo(tm) premounted stent system. This change applies only to the 9 mm length nir(tm) primo(tm) premounted stent system with the 3. 0 mm, 3. 5 mm, and 4. 0 mm balloon diameters.
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