Zenith Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S006 · decided 2023-06-07
Approval details
- PMA number
- P140016
- Supplement
- S006
- 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
- 2023-05-10
- Decision date
- 2023-06-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval for an added incoming inspection step for the introducer sheath.
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