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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.
 
DeviceXACT Carotid Stent System
Generic NameStent, carotid
ApplicantAbbott Vascular, Inc.
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP040038
Supplement NumberS039
Date Received11/12/2021
Decision Date12/08/2021
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  
Supplier and manufacturing changes to the Exit Port Molding (EPM) component of the XACT Carotid Stent System.
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