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 | RelayPro Thoracic Stent-Graft System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Bolton Medical, Inc.799 International Parkwaysunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-12 |
| Decision Date | 2022-08-11 |
| PMA | P200045 |
| Supplement | S003 |
| 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 Parkway sunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement replacement Of Manufacturing Equipment For A Delivery System Component Of RelayPro And RelayPlus Thoracic Stent-Graft Systems |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200045 | Original Filing | |
| S003 | 2022-07-12 | 30-day Notice |
| S002 | ||
| S001 | 2021-09-03 | Normal 180 Day Track No User Fee |