ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
FDA premarket approval P140016/S004 · decided 2021-12-22
Approval details
- PMA number
- P140016
- Supplement
- S004
- 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
- 2021-12-03
- Decision date
- 2021-12-22
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- Approval for 100% visual QC inspection step for release wires.
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