PMA P190015S003
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- Product code
- MIH
- Decision date
- 2020-10-30
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval of the statistical analysis plan for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- TREO Abdominal Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P190015
- Supplement
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-10-30
- Decision code
- APPR
- Date received
- 2020-08-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the statistical analysis plan for the post-approval study (PAS) protocol.