TREO® Abdominal Stent-Graft System

FDA Premarket Approval P190015 S010

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

• Device: TREO® Abdominal Stent-Graft System
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: Bolton Medical Inc.799 International Pkwysunrise, FL 33325 PMA NumberP190015 Supplement NumberS010 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Date Received: 2022-12-23
• Decision Date: 2023-01-20
• PMA: P190015
• Supplement: S010
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Bolton Medical Inc.; 799 International Pkwy; sunrise, FL 33325 PMA NumberP190015 Supplement NumberS010 Date Received12/23/2022 Decision Date01/20/2023 Product Code MIH Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement ; approval For Implementation Of Updates To The Procedural Guidance In The Instructions For Use (IFU) And MR Compatibility Information In The IFU And Patient Implant Card

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

Device ID	PMA	Supp
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