PMA P190015S006
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S006
- Product code
- MIH
- Decision date
- 2020-10-30
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Use an alternative sterilization load configuration for the TREO Abdominal Stent-Graft System.
Current openFDA PMA Record#
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S006
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-30
- Decision code
- OK30
- Date received
- 2020-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an alternative sterilization load configuration for the TREO Abdominal Stent-Graft System.