|
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 | S013 |
Date Received | 11/17/2023 |
Decision Date | 12/13/2023 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement modifications to the inspection plan for TREO stent-grafts that are manufactured at Terumo Vietnam Corporation (TVC) |