Zenith Alpha Thoracic Endovascular Graft
FDA premarket approval P140016/S001 · decided 2017-07-28
Approval details
- PMA number
- P140016
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Zenith Alpha Thoracic Endovascular Graft
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook Medical Incorporated
- Date received
- 2017-06-28
- Decision date
- 2017-07-28
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval to remove blunt thoracic aortic injury from the indications for use and remove references to the smaller diameter grafts that have been removed from the market.
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