Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S114 |
Date Received | 05/08/2023 |
Decision Date | 06/06/2023 |
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 Addition of alternate suppliers to perform the EtO bioburden reduction process for the Endurant, Endurant II and Endurant IIs Stent Graft System and the Valiant Thoracic Stent Graft with the Captivia Delivery System. |
|
|