PMA P120006S034
- Device
- Alto Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S034
- Product code
- MIH
- Decision date
- 2020-04-24
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Add a previously approved ethylene oxide sterilization supplier for the Alto Abdominal Stent Graft System.
Current openFDA PMA Record#
- Device
- Alto Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S034
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-04-24
- Decision code
- OK30
- Date received
- 2020-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a previously approved ethylene oxide sterilization supplier for the Alto Abdominal Stent Graft System.