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.
A change to the nylon sub-supplier, the anti-block additive used, and the extrusion process used in the manufacturing of the product pouches for the treo abdominal stent-graft system and the relay thoracic stent-graft with plus delivery system
| Device | TREO Abdominal Stent-Graft System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Bolton Medical Inc. |
| Date Received | 2020-11-24 |
| Decision Date | 2020-12-17 |
| PMA | P190015 |
| Supplement | S008 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190015 | Original Filing | |
| S010 | 2022-12-23 | Special (immediate Track) |
| S009 | 2021-01-25 | Real-time Process |
| S008 | 2020-11-24 | 30-day Notice |
| S007 | 2020-11-23 | Normal 180 Day Track No User Fee |
| S006 | 2020-10-29 | 30-day Notice |
| S005 | 2020-09-14 | 30-day Notice |
| S004 | ||
| S003 | ||
| S002 | 2020-07-23 | Special (immediate Track) |
| S001 | 2020-06-03 | Normal 180 Day Track No User Fee |