PMA P020018S041
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S041
- Product code
- MIH
- Decision date
- 2011-12-14
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENT¿S DELIVERY SYSTEMS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S041
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-12-14
- Decision code
- APPR
- Date received
- 2011-10-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ANCILLARY COMPONENT¿S DELIVERY SYSTEMS FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT PRODUCT LINE.