|
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 |
Date Received | 08/31/2018 |
Decision Date | 04/11/2019 |
Product Code |
QCT |
Docket Number | 19M-1763 |
Notice Date | 04/12/2019 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02522884
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 3.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 |