|
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 | S018 |
Date Received | 03/28/2024 |
Decision Date | 05/03/2024 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modification of the design and manufacturing procedure of the delivery system distal cap |