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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 (4F, 1.5-4.5mm)
Generic NameScaffold, dissection repair
ApplicantPhilips Image Guided Therapy Corporation (Formerly Intact)
5905 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP190027
Supplement NumberS005
Date Received08/29/2022
Decision Date11/09/2022
Withdrawal Date12/17/2025
Product Code QCT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02942966
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the post-approval labeling update to include the 36-month outcomes of the TOBA II BTK Post-Approval Study.
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