PMA P020018S033
- Device
- ZENITH AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S033
- Product code
- MIH
- Decision date
- 2009-07-24
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING A CHANGE TO CONDITIONAL MR COMPATIBILITY.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S033
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-07-24
- Decision code
- APPR
- Date received
- 2009-06-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES INCLUDING A CHANGE TO CONDITIONAL MR COMPATIBILITY.