Approval for the venovo venous stent system. The device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.
| Device | Venovo Venous Stent System |
| Classification Name | Stent, Iliac Vein |
| Generic Name | Stent, Iliac Vein |
| Applicant | Bard Peripheral Vascular, Inc. |
| Date Received | 2018-09-14 |
| Decision Date | 2019-03-13 |
| PMA | P180037 |
| Supplement | S |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bard Peripheral Vascular, Inc. 1625 West Third Street tempe, AZ 85281 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180037 | Original Filing | |
| S012 | 2023-01-06 | 30-day Notice |
| S011 | 2022-05-19 | 30-day Notice |
| S010 | 2022-04-26 | 30-day Notice |
| S009 | 2022-03-25 | 30-day Notice |
| S008 | 2021-10-15 | Real-time Process |
| S007 | 2021-08-09 | Normal 180 Day Track No User Fee |
| S006 | 2021-07-09 | 30-day Notice |
| S005 | 2021-05-04 | 30-day Notice |
| S004 | 2020-09-02 | 30-day Notice |
| S003 | 2020-08-31 | 30-day Notice |
| S002 | 2020-08-03 | 30-day Notice |
| S001 | 2020-08-03 | 30-day Notice |