Premarket Approval (PMA)

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.

• Device: Tack Endovascular System (4F, 1.5-4.5mm)
• Generic Name: Scaffold, dissection repair
• Applicant: Philips Image Guided Therapy Corporation (Formerly Intact); 5905 Nathan Ln. N.; Plymouth, MN 55442
• PMA Number: P190027
• Supplement Number: S002
• Date Received: 09/08/2021
• Decision Date: 10/08/2021
• Withdrawal Date: 12/17/2025
• Product Code: QCT
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Alternate supplier for the tip component of the delivery system.