PMA P120006S037
- Device
- Alto Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S037
- Product code
- MIH
- Decision date
- 2020-10-09
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for the Alto Randomized Post-Approval Study protocol.
Current openFDA PMA Record#
- Device
- Alto Abdominal Stent Graft System
- Applicant
- Endologix, LLC
- PMA number
- P120006
- Supplement
- S037
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-09
- Decision code
- APPR
- Date received
- 2020-06-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the Alto Randomized Post-Approval Study protocol.