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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 PREMOUNTED STENT SYSTEM
Generic NameSTENT, RENAL
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP060006
Supplement NumberS015
Date Received08/02/2010
Decision Date09/01/2010
Product Code NIN 
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  
REDUCTION OF IN-PROCESS DESTRUCTIVE TESTING AND ASSOCIATED MEASUREMENTS PERFORMED ON THE BALLOON COMPONENTS OF THE DEVICES DURING THE BALLOON MOLDING OPERATION.
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