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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.
 
DeviceENDOTEX NEXSTENT CAROTID STENT AND MONORAIL
Generic NameStent, carotid
ApplicantBoston Scientific
One Scimed Pl.
Ms A350
Maple Grove, MN 55311
PMA NumberP050025
Supplement NumberS002
Date Received03/07/2007
Decision Date04/10/2007
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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