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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 (6F)
Generic NameScaffold, dissection repair
ApplicantPhilips Image Guided Therapy Corporation
5905 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP180034
Supplement NumberS005
Date Received06/10/2021
Decision Date09/07/2021
Withdrawal Date12/17/2025
Product Code QCT 
Advisory Committee Cardiovascular
Clinical TrialsNCT02522884
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 labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study.
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