PMA P040002S039
- Device
- POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S039
- Product code
- MIH
- Decision date
- 2013-04-16
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF BILATERAL PERCUTANEOUS ACCESS TO THE DEVICE LABELING.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S039
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-04-16
- Decision code
- APPR
- Date received
- 2012-07-05
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR THE ADDITION OF BILATERAL PERCUTANEOUS ACCESS TO THE DEVICE LABELING.