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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(R) PREMOUNTED STENT SYSTEM
ApplicantBoston Scientific Corp.
One Boston Scientific Place
Natick, MA 01760
PMA NumberP980001
Supplement NumberS033
Date Received05/16/2001
Decision Date06/07/2001
Withdrawal Date 08/13/2007
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE ACCEPTANCE CRITERIA FOR AN IN-PROCESS INSPECTION STEP FOR THE BALLOON COMPONENT USED IN THE MANUFACTURE OF THE NIR(R) PREMOUNTED STENT SYSTEMS.
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