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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.
DeviceENROUTE Transcarotid Stent System
Generic Namestent, carotid
1213 innsbruck drive
sunnyvale, CA 94089
PMA NumberP140026
Supplement NumberS020
Date Received05/12/2022
Decision Date07/20/2022
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for receiving, inspection, and distribution of finished goods at a manufacturing site located at 14755 27th Ave N, Plymouth, MN 55447.