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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceTack Endovascular System (6F)
Generic NameScaffold, dissection repair
ApplicantPhilips Image Guided Therapy Corporation
5905 Nathan Lane North
Plymouth, MN 55442
PMA NumberP180034
Date Received08/31/2018
Decision Date04/11/2019
Product Code QCT 
Docket Number 19M-1763
Notice Date 04/12/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT02522884
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007