PMA P020018
- Device
- Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch (ZBIS)
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S060
- Product code
- MIH
- Decision date
- 2026-08-04
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- changes to the supplier of packaging materials
Current openFDA PMA Record#
- Device
- Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch (ZBIS)
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S069
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-08-04
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the supplier of packaging materials