PMA P040002S018
- Device
- POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S018
- Product code
- MIH
- Decision date
- 2008-10-08
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR SUPRARENAL VERSIONS OF THE POWERLINK BIFURCATED STENT GRAFTS AND ACCESSORIES.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM, 25MM, 28MM, AND 34MM SUPRARENAL BIFURCATED STENT GRAFTS AND ACCESSORIES
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S018
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-10-08
- Decision code
- APPR
- Date received
- 2008-04-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SUPRARENAL VERSIONS OF THE POWERLINK BIFURCATED STENT GRAFTS AND ACCESSORIES.