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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 | S004 |
Date Received | 09/04/2020 |
Decision Date | 12/03/2020 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an increase in the labeled shelf life for the bifurcate and cuff devices in the TREO Abdominal Stent-Graft System (TREO) product family from 2 years to 3 years. |