|
Device | Valiant Thoracic Stent Graft with the Captivia Delivery System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S060 |
Date Received | 12/20/2023 |
Decision Date | 12/29/2023 |
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 implementation of changes in supplier and minor manufacturing changes for components of the Medtronic Valiant Captivia Delivery System |