Zenith Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S002 · decided 2021-04-27
Approval details
- PMA number
- P140016
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Zenith Alpha Thoracic Endovascular Graft
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook Medical Incorporated
- Date received
- 2020-10-29
- Decision date
- 2021-04-27
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval for labeling update which incorporates the final 5-year results from the post-approval study for continued follow-up of pivotal and continued access patients enrolled in the premarket study.
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