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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 NumberS043
Date Received06/27/2023
Decision Date02/07/2024
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the expansion of the indications to include use of the XACT Carotid Stent System in conjunction with the ENROUTE NPS device during Transcarotid Artery Revascularization (TCAR) procedures
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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