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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 Lane North
Plymouth, MN 55442
PMA NumberP180034
Supplement NumberS007
Date Received02/23/2022
Decision Date05/24/2022
Product Code QCT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change of quality management system and design ownership from Intact Vascular, Inc. to Philips Image Guided Therapy Corporation.
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