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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.
 
DeviceNEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
Generic NameStent, carotid
ApplicantBoston Scientific
One Scimed Pl.
Ms A350
Maple Grove, MN 55311
PMA NumberP050025
Supplement NumberS008
Date Received03/10/2008
Decision Date04/09/2008
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ESTABLISHMENT OF A NEW TEST TO THE INSPECTION OF INCOMING SUBASSEMBLIES.
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