PMA P020018S024
- Device
- ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S024
- Product code
- MIH
- Decision date
- 2007-07-05
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO MARKET THE 36 MM DIAMETER ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2007-07-05
- Decision code
- APPR
- Date received
- 2007-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO MARKET THE 36 MM DIAMETER ZENITH AAA ENDOVASCULAR GRAFT/ZENITH RENU AAA ANCILLARY GRAFT