PMA P020018S059
- Device
- Zenith AAA Endovascular Graft
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S059
- Product code
- MIH
- Decision date
- 2020-10-08
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for the use of a Stent Orientation tool in the manufacturing of the Zenith AAA Endovascular Graft.
Current openFDA PMA Record#
- Device
- Zenith AAA Endovascular Graft
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S059
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-08
- Decision code
- APPR
- Date received
- 2020-09-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of a Stent Orientation tool in the manufacturing of the Zenith AAA Endovascular Graft.