ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
FDA premarket approval P140016/S015 · decided 2025-09-18
Approval details
- PMA number
- P140016
- Supplement
- S015
- Supplement type
- Real-Time Process
- 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
- 2025-06-26
- Decision date
- 2025-09-18
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval for a change in coating for the delivery system of the Zenith Alpha 2 Thoracic Endovascular Graft
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