Zenith® Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S010 · decided 2024-09-25
Approval details
- PMA number
- P140016
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zenith® Alpha Thoracic Endovascular Graft
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook Medical Incorporated
- Date received
- 2024-03-29
- Decision date
- 2024-09-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- approval for changes associated with introduction systems for proximal and distal components as well as the distal extension of the Zenith Alpha Thoracic Endovascular Graft System
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