- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S002
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-08-20
- Decision code
- APPR
- Date received
- 2020-07-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of an in-process inspection step in the manufacturing of the TREO Abdominal Stent-Graft System.