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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 Drive
Santa Clara, CA 95054
PMA NumberP040038
Supplement NumberS034
Date Received01/24/2019
Decision Date02/20/2019
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  
Add a third sterilization chamber at the contract sterilizer.
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