PMA P120006S030
- Device
- Ovation iX Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S030
- Product code
- MIH
- Decision date
- 2018-05-08
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for the modification of the inner handle of the Ovation iX aortic body delivery system.
Current openFDA PMA Record#
- Device
- Ovation iX Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S030
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2018-05-08
- Decision code
- APPR
- Date received
- 2018-02-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the modification of the inner handle of the Ovation iX aortic body delivery system.