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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.
 
DeviceExpress SD Monorail Premounted Stent Systemt
Generic NameSTENT, RENAL
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP060006
Supplement NumberS091
Date Received04/06/2018
Decision Date09/07/2018
Product Code NIN 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updating the optimized BSC2000-2 cycle conducted in Chamber 7 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software.
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