PMA P020018S048
- Device
- ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S048
- Product code
- MIH
- Decision date
- 2013-05-09
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S048
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-05-09
- Decision code
- APPR
- Date received
- 2013-03-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.