PMA P020018S030
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S030
- Product code
- MIH
- Decision date
- 2008-12-19
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ADDITION OF A CONTRACT MANUFACTURER IN THE CONSTRUCTION OF SUBASSEMBLY COMPONENTS.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S030
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-12-19
- Decision code
- OK30
- Date received
- 2008-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A CONTRACT MANUFACTURER IN THE CONSTRUCTION OF SUBASSEMBLY COMPONENTS.