|
Device | Tack Endovascular System (6F) |
Generic Name | Scaffold, dissection repair |
Applicant | Philips Image Guided Therapy Corporation 5905 Nathan Lane North Plymouth, MN 55442 |
PMA Number | P180034 |
Supplement Number | S005 |
Date Received | 06/10/2021 |
Decision Date | 09/07/2021 |
Product Code |
QCT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02522884
|
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 labeling updates which incorporate the final 36-month results from the TOBA II Post Approval Study. |