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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 (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS020
Date Received05/26/2000
Decision Date06/13/2000
Withdrawal Date08/13/2007
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN MANUFACTURING PROCESS TO REMOVE TWO INSPECTION STEPS FOR MARKERBAND PLACEMENT ON THE NIR(TM) W/SOX(TM) PREMOUNTED STENT DELIVERY SYSTEM.
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