TREO Abdominal Stent-Graft System

FDA Premarket Approval P190015 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at terumo vietnam co. , ltd (lot 44a-b-c, quang minh industrial zone, me linh district, hanoi city, vietnam) for kitting and sewing processes of treo abdominal stent graft

• Device: TREO Abdominal Stent-Graft System
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: Bolton Medical Inc.
• Date Received: 2020-11-23
• Decision Date: 2020-12-16
• PMA: P190015
• Supplement: S007
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325

Supplemental Filings

Supplement Number	Date	Supplement Type
P190015		Original Filing
S010	2022-12-23	Special (immediate Track)
S009	2021-01-25	Real-time Process
S008	2020-11-24	30-day Notice
S007	2020-11-23	Normal 180 Day Track No User Fee
S006	2020-10-29	30-day Notice
S005	2020-09-14	30-day Notice
S004
S003
S002	2020-07-23	Special (immediate Track)
S001	2020-06-03	Normal 180 Day Track No User Fee

NIH GUDID Devices

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