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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.
 
DeviceCAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Generic NameStent, carotid
ApplicantBoston Scientific Corp
Three Scimed Pl.
Maple Grove, MN 55311
PMA NumberP050019
Supplement NumberS005
Date Received04/08/2010
Decision Date01/07/2011
Product Code NIM 
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
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