Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS007
Date Received02/23/2022
Decision Date05/24/2022
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 a change of quality management system and design ownership from Intact Vascular, Inc. to Philips Image Guided Therapy Corporation.
-
-