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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 ON RANGER PREMOUNTED STENT SYSTEMS
Generic Namecatheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP980001
Supplement NumberS002
Date Received09/14/1998
Decision Date08/03/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the postapproval study protocol for the nir on(tm) ranger w/sox(tm) and nir on(tm) ranger(tm) premounted stent systems.
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