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.
Approval of the protocol for the relaypro post approval surveillance study. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p200045.
Device | RelayPro Thoracic Stent-Graft System |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Bolton Medical, Inc. |
Date Received | 2021-09-03 |
Decision Date | 2021-11-16 |
PMA | P200045 |
Supplement | S001 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review | No |
Combination Product | No |
Applicant Address | Bolton Medical, Inc. 799 International Parkway sunrise, FL 33325 |
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 |