PMA P040002S045
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S045
- Product code
- MIH
- Decision date
- 2014-02-06
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF A CONTRACT STERILIZER LOCATED AT STERIS-ISOMEDIX SERVICES, IN TEMECULA, CALIFORNIA.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S045
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-02-06
- Decision code
- APPR
- Date received
- 2013-12-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A CONTRACT STERILIZER LOCATED AT STERIS-ISOMEDIX SERVICES, IN TEMECULA, CALIFORNIA.