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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.
 
DeviceNIROYAL(R) ELITE OVER-THE-WIRE STENT SYSTEM
ApplicantBoston Scientific Corp
One Boston Scientific Pl.
Natick,, MA 01760
PMA NumberP980001
Supplement NumberS030
Date Received03/12/2001
Decision Date04/10/2001
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  
EMODIFICATION TO THE ACCEPTANCE CRITERIA FOR THE GEL LUMP SIZE TO THE SOX(TM) COMPONENT FROM 0.005" TO <= 0.010".
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