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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 NumberS012
Date Received09/20/1999
Decision Date03/20/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the indications for use statement and the instructions for use (ifu) to include the results of the nine-month follow-up of the nirvana clinical trial for the nir on ranger and nir primo premounted stent systems.
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