PMA P990020S034
- Device
- ANEURX STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P990020
- Supplement
- S034
- Product code
- MIH
- Decision date
- 2011-09-13
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO INCORPORATE INFORMATION FROM COMPLETED CLINICAL STUDIES.
Current openFDA PMA Record
- Device
- ANEURX STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P990020
- Supplement
- S034
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-09-13
- Decision code
- APPR
- Date received
- 2009-03-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS TO INCORPORATE INFORMATION FROM COMPLETED CLINICAL STUDIES.