PMA P140016S004
- Device
- ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
- Applicant
- Cook Medical Incorporated
- PMA number
- P140016
- Supplement
- S004
- Product code
- MIH
- Decision date
- 2021-12-22
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for 100% visual QC inspection step for release wires.
Current openFDA PMA Record#
- Device
- ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
- Applicant
- Cook Medical Incorporated
- PMA number
- P140016
- Supplement
- S004
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-12-22
- Decision code
- APPR
- Date received
- 2021-12-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for 100% visual QC inspection step for release wires.