PMA P040002S028
- Device
- POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S028
- Product code
- MIH
- Decision date
- 2010-05-13
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO THE HEMOSTASIS HANDLE ASSEMBLY OF THE DEVICE.
Current openFDA PMA Record#
- Device
- POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S028
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2010-05-13
- Decision code
- OK30
- Date received
- 2010-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE HEMOSTASIS HANDLE ASSEMBLY OF THE DEVICE.