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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 STENT DELIVERY SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS038
Date Received08/30/2001
Decision Date09/26/2001
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternative manufacturing process to produce balloons for nir(r) and niroyal(r) stent delivery systems. The alternative process affects only the method of stretching the balloon tubing prior to molding the balloon.
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