This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Venovo™ Venous Stent System |
| Generic Name | Stent, Iliac Vein |
| Applicant | Bard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS012 Date Received01/06/2023 Decision Date02/02/2023 Product Code QAN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2023-01-06 |
| Decision Date | 2023-02-02 |
| PMA | P180037 |
| Supplement | S012 |
| Product Code | QAN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bard Peripheral Vascular, Inc. 1625 West Third Street tempe, AZ 85281 PMA NumberP180037 Supplement NumberS012 Date Received01/06/2023 Decision Date02/02/2023 Product Code QAN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval Of A New Supplier For A Delivery System Wheel Sub-assembly |
| 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 |