PMA P040002S026
- Device
- POWERLINK SYSTEM FOR AAA
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S026
- Product code
- MIH
- Decision date
- 2010-07-28
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE SUPRARENAL PROXIMAL EXTENSION ACCESSORY AND FOR ADDITIONAL LENGTHS OF SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORIES.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM FOR AAA
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S026
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2010-07-28
- Decision code
- APPR
- Date received
- 2010-02-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE SUPRARENAL PROXIMAL EXTENSION ACCESSORY AND FOR ADDITIONAL LENGTHS OF SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORIES.