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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIR PREMOUNTED STENT SYSTEMS
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS012
Date Received09/20/1999
Decision Date03/20/2000
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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