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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.
 
DeviceTack Endovascular System
Generic Namescaffold, dissection repair
ApplicantPhilips Image Guided Therapy Corporation
5905 nathan lane north
plymouth, MN 55442
PMA NumberP180034
Supplement NumberS004
Date Received02/23/2021
Decision Date03/16/2021
Product Code QCT 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Alternate supplier for the tip component of the delivery system.
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