|
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 | S038 |
Date Received | 04/05/2019 |
Decision Date | 05/05/2019 |
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 Implement a bioburden reduction step in the manufacturing process for the Endurant and Valiant Captivia endovascular grafts. |