Zenith Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S009 · decided 2023-12-15
Approval details
- PMA number
- P140016
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zenith Alpha Thoracic Endovascular Graft
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook Medical Incorporated
- Date received
- 2023-11-17
- Decision date
- 2023-12-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- change in the PTFE wire coating of the nitinol release wires used in the introduction system of the Zenith Alpha Thoracic Endovascular Graft and Zenith Dissection Endovascular System
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