PMA P040002S009
- Device
- POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S009
- Product code
- MIH
- Decision date
- 2007-03-29
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- CHANGE TO THE SUREPASS CONTRALATERAL LIMB SHEATH/GUIDEWIRE ASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S009
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2007-03-29
- Decision code
- OK30
- Date received
- 2007-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SUREPASS CONTRALATERAL LIMB SHEATH/GUIDEWIRE ASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM.