TREO Abdominal Stent-Graft System

FDA Premarket Approval P190015 S001

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 of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p190015

• Device: TREO Abdominal Stent-Graft System
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: Bolton Medical Inc.
• Date Received: 2020-06-03
• Decision Date: 2020-07-31
• PMA: P190015
• Supplement: S001
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• 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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