PMA P040002S058
- Device
- Endologix Powerlink System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S058
- Product code
- MIH
- Decision date
- 2017-06-02
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for the removal of an on-going sampling plan for the AFX2 Endovascular AAA System.
Current openFDA PMA Record#
- Device
- Endologix Powerlink System
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S058
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-06-02
- Decision code
- APPR
- Date received
- 2017-02-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the removal of an on-going sampling plan for the AFX2 Endovascular AAA System.