PMA P040002S024
- Device
- POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S024
- Product code
- MIH
- Decision date
- 2010-01-06
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A CHANGE IN GRAFT PROCESSING PROCEDURES.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2010-01-06
- Decision code
- APPR
- Date received
- 2009-06-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN GRAFT PROCESSING PROCEDURES.