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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 (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP980001
Supplement NumberS020
Date Received05/26/2000
Decision Date06/13/2000
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing process to remove two inspection steps for markerband placement on the nir(tm) w/sox(tm) premounted stent delivery system.
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