|
Device | Valiant Thoracic Stent Graft with Captiva 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 | S040 |
Date Received | 07/14/2020 |
Decision Date | 07/23/2020 |
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 New primary supplier and raw material suppliers for the Endurant and Valiant Captivia packaging trays; and dimensional changes to the tabs on the Endurant and Valiant Captivia packaging trays. |