PMA P040002S029
- Device
- POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S029
- Product code
- MIH
- Decision date
- 2011-01-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR CONSOLIDATION OF ALL INNER CORE CONFIGURATIONS FOR THE 17FR INTUITRAK ACCESSORY DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POWERLINK STENT GRAFT SYSTEM WITH INTUITRAK DELIVERY SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS.
Current openFDA PMA Record#
- Device
- POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S029
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-01-20
- Decision code
- APPR
- Date received
- 2010-11-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CONSOLIDATION OF ALL INNER CORE CONFIGURATIONS FOR THE 17FR INTUITRAK ACCESSORY DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME POWERLINK STENT GRAFT SYSTEM WITH INTUITRAK DELIVERY SYSTEM AND IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSMS.