PMA P020018S007
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S007
- Product code
- MIH
- Decision date
- 2006-03-23
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY SUBMISSION FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT.
Current openFDA PMA Record#
- Device
- ZENITH FLEX AAA ENDOVASCULAR GRAFT
- Applicant
- Cook, Inc.
- PMA number
- P020018
- Supplement
- S007
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-03-23
- Decision code
- APPR
- Date received
- 2005-10-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY SUBMISSION FOR THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT.