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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 NumberS001
Date Received08/02/2019
Decision Date01/28/2020
Withdrawal Date12/17/2025
Product Code QCT 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Tack Endovascular System® (6F, 4.0-8.0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).
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