|
Device | TREO Abdominal Stent-Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Bolton Medical Inc. 799 International Pkwy Sunrise, FL 33325 |
PMA Number | P190015 |
Supplement Number | S003 |
Date Received | 08/12/2020 |
Decision Date | 10/30/2020 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01328197
|
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 statistical analysis plan for the post-approval study (PAS) protocol. |