PMA P020018S039
- Device
- ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S039
- Product code
- MIH
- Decision date
- 2012-07-17
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MODIFIED LABEL TO INCORPORATE INFORMATION FROM THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S039
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-07-17
- Decision code
- APPR
- Date received
- 2011-06-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A MODIFIED LABEL TO INCORPORATE INFORMATION FROM THE POST-APPROVAL STUDY.