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. |
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Device | Medtronic CoreValve™ Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100021 |
Supplement Number | S120 |
Date Received | 03/29/2024 |
Decision Date | 04/10/2024 |
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 internal facility transfer of component extrusion and secondary cutting manufacturing operations |
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