|
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 | S001 |
Date Received | 08/02/2019 |
Decision Date | 01/28/2020 |
Product Code |
QCT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Tack Endovascular System® (6F, 4.0-8.0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s). |