| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| 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 |
|---|
| Date Received | 10/01/2019 |
|---|
| Decision Date | 04/10/2020 |
|---|
| Product Code |
QCT |
| Docket Number | 20M-1286 |
|---|
| Notice Date | 04/14/2020 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials | NCT02942966
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
Approval for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) 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 |
|
|
