PMA P190015S009

Device: TREO Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S009
Product code: MIH
Decision date: 2021-04-19
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for an increase in the labeled shelf life for the straight extension stent-grafts in the TREO Abdominal Stent-Graft System (TREO) product family from 2 years to 3 years.

Current openFDA PMA Record#

Device: TREO Abdominal Stent-Graft System
Applicant: Bolton Medical, Inc.
PMA number: P190015
Supplement: S009
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-04-19
Decision code: APPR
Date received: 2021-01-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an increase in the labeled shelf life for the straight extension stent-grafts in the TREO Abdominal Stent-Graft System (TREO) product family from 2 years to 3 years.