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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 Pl.
Ms A350
Maple Grove, MN 55311
PMA NumberP050025
Supplement NumberS003
Date Received04/12/2007
Decision Date05/10/2007
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN INSPECTION PROCEDURE AND A NEW VISUAL STANDARD THAT WILL BE IMPLEMENTED AS PART OF ROUTINE RECEIVING AND INSPECTION FOR A SUBASSEMBLY USED WITH THE NEXSTENT CAROTID STENT SYSTEM.
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