|
Device | Tack Endovascular System (4F) |
Generic Name | Scaffold, dissection repair |
Applicant | Philips Image Guided Therapy Corporation (formerly Intact) 5905 Nathan Lane North Plymouth, MN 55442 |
PMA Number | P190027 |
Supplement Number | S003 |
Date Received | 01/11/2022 |
Decision Date | 09/29/2022 |
Product Code |
QCT |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate supplier for the delivery system. |