Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch
Cook, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT · Cardiovascular
Open FDA's page for this record- PMA number
- P020018
- Supplement number
- S070
- Applicant
- Cook, Inc.
- Street 1
- 750 Daniels Way
- Street 2
- P.O. Box 489
- City
- Bloomington
- State
- IN
- Zip
- 47402
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Trade name
- Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch
- Product code
- MIH
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-08-20
- Decision date
- 2026-09-17
- Decision code
- OK30
- Ao statement
- approval for delivery system manufacturing changes for Zenith Fenestrated AAA Endovascular Graft and Zenith Iliac Branch
- Harmonized identifiers (openFDA)
- Device name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 9710641, 3002808486, 3011324393, 3009380063, 3003678543, 3005580113, 3005562917, 9680271, 3002807314, 9616099, 1820334, 2953200, 3007738736, 3011063223, 1721686, 3006131984, 3009526575, 1054811, 1721676, 3008011247, 9680654, 2011171, 3008307705, 3012102437, 2247858, 9617601, 3013164176, 1219313, 3004497303, 3007284313, 2017233, 9612164, 2030624, 3016521833
- FEI number
- 3003259710, 3003528016, 3002808486, 3011324393, 3009380063, 3003678543, 3005580113, 3005562917, 3002807314, 1820334, 3007738736, 3011063223, 1721686, 3003565456, 3006131984, 3009526575, 1721676, 3008011247, 3002534070, 1000114185, 1000135961, 2011171, 3008307705, 3012102437, 3000206435, 3013164176, 1219313, 3004497303, 3007530363, 3002806434, 3007284313, 2017233, 3001452571, 3016521833