|
Device | RelayPro Thoracic Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Bolton Medical, Inc. 799 International Parkway Sunrise, FL 33325 |
PMA Number | P200045 |
Supplement Number | S001 |
Date Received | 09/03/2021 |
Decision Date | 11/16/2021 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02818972
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the RelayPro Post Approval Surveillance Study. |