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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 SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980001
Supplement NumberS010
Date Received07/09/1999
Decision Date07/22/1999
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested modification of the dimensions of two packaging components (packaging tube and balloon/stent protector) to allow for easier device removal.
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