- Device
- Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System
- Applicant
- Cook Medical Incorporated
- PMA number
- P140016
- Supplement
- S017
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-05-21
- Decision code
- OK30
- Date received
- 2026-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a new supplier for a component of delivery systems of the Zenith (Flex) AAA Endovascular Graft, Zenith Renu AAA Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, Zenith Alpha & Alpha2 Thoracic Endovascular Graft, Zenith Dissection Endovascular System