Zenith Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S005 · decided 2022-04-14
Approval details
- PMA number
- P140016
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- 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
- 2022-03-18
- Decision date
- 2022-04-14
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval for an additional seal on one side of the Zenith Alpha Thoracic Endovascular Graft primary packaging and new specifications for the position of an already applied seal on the opposite side.
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