PMA P020018S047
- Device
- ZENITH AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S047
- Product code
- MIH
- Decision date
- 2012-12-12
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- LOWERING OF THE ACCEPTANCE TESTING CRITERION FOR AN IN-PROCESS TESTING.
Current openFDA PMA Record#
- Device
- ZENITH AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S047
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-12-12
- Decision code
- OK30
- Date received
- 2012-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- LOWERING OF THE ACCEPTANCE TESTING CRITERION FOR AN IN-PROCESS TESTING.