PMA P190015S005
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2020-10-16
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Implementation of updates to the manufacturing process for the TREO delivery system.
Current openFDA PMA Record#
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-16
- Decision code
- OK30
- Date received
- 2020-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of updates to the manufacturing process for the TREO delivery system.