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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
Applicant
Intact Vascular, Inc.
1285 drummers lane, suite 200
wayne, PA 19087
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 Trials NCT02522884
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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