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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 SCIMED, INC.
PMA NumberP980001
Supplement NumberS032
Date Received05/07/2001
Decision Date05/29/2001
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a reduction of the internal diameter of the proximal shaft from 0. 0205" to 0. 0190" on the following premounted stent systems: noroyal(tm) advance, niroyal(tm) elite and nir(tm) elite.
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