|
Device | Valiant Captivia Stent Graft ith 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 | S050 |
Date Received | 11/30/2021 |
Decision Date | 12/10/2021 |
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 Manufacturing changes to be implemented by the first-tier supplier (Phillips) of stent stop components for the delivery system of Valiant Captivia. |