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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 CORONARY STENT WITH DELIVERY SYSTEM
ApplicantBoston Scientific Corp.
One Boston Scientific Place
Natick, MA 01760
PMA NumberP980001
Supplement NumberS035
Date Received07/12/2001
Decision Date08/16/2001
Withdrawal Date 08/13/2007
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE WARNING STATEMENT IN THE INSTRUCTIONS FOR USE MANUAL.
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