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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 AND MONORAIL DELIVERY SYSTEM
Generic NameSTENT, CAROTID
ApplicantBOSTON SCIENTIFIC
ONE SCIMED PLACE
MS A350
MAPLE GROVE, MN 55311-1566
PMA NumberP050025
Supplement NumberS006
Date Received07/26/2007
Decision Date08/24/2007
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A 100% INSPECTION TEST TO BE IMPLEMENTED IN RECEIVING INSPECTION AND A 100% IN-PROCESS VISUAL VERIFICATION TO ENSURE THAT CONNECTOR BLOCKS PROPERLY TRANSMIT UV LIGHT.
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