PMA P040002S019
- Device
- ENDOLOGIX, INC. POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S019
- Product code
- MIH
- Decision date
- 2008-11-04
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE 34MM INFRARENAL PROXIMAL CUFF ACCESSORY FOR THE POWERLINK SYSTEM.
Current openFDA PMA Record#
- Device
- ENDOLOGIX, INC. POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S019
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-11-04
- Decision code
- APPR
- Date received
- 2008-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE 34MM INFRARENAL PROXIMAL CUFF ACCESSORY FOR THE POWERLINK SYSTEM.