PMA P020018S029
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S029
- Product code
- MIH
- Decision date
- 2008-11-17
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN ALTERNATE VENDOR FOR POLYESTER SUTURE.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S029
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-11-17
- Decision code
- APPR
- Date received
- 2008-08-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR AN ALTERNATE VENDOR FOR POLYESTER SUTURE.