PMA P120006S029
- Device
- Ovation iX Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S029
- Product code
- MIH
- Decision date
- 2017-09-05
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Add a qualified alternate supplier for Ethylene Oxide (EO) sterilization for the Ovation iX Abdominal Stent Graft System.
Current openFDA PMA Record#
- Device
- Ovation iX Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S029
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-09-05
- Decision code
- OK30
- Date received
- 2017-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a qualified alternate supplier for Ethylene Oxide (EO) sterilization for the Ovation iX Abdominal Stent Graft System.