PMA P020018S045
- Device
- ZENITH FENESTRATED AAA ENDOVASULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S045
- Product code
- MIH
- Decision date
- 2012-07-26
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- ZENITH FENESTRATED AAA ENDOVASULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S045
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-07-26
- Decision code
- APPR
- Date received
- 2012-06-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE FOR THE DEVICE.