- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S008
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-12-17
- Decision code
- OK30
- Date received
- 2020-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the nylon sub-supplier, the anti-block additive used, and the extrusion process used in the manufacturing of the product pouches for the Treo Abdominal Stent-Graft System and the Relay Thoracic Stent-Graft with Plus Delivery System