|
Device | Tack Endovascular System (4F, 1.5-4.5mm) |
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 | S005 |
Date Received | 08/29/2022 |
Decision Date | 11/09/2022 |
Product Code |
QCT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02942966
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the post-approval labeling update to include the 36-month outcomes of the TOBA II BTK Post-Approval Study. |