RelayPlus Thoracic Stent-Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P110038 S016

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 updates to the instructions for use including clarifications regarding device deployment directions, as well as other minor administrative and editorial changes.

• Device: RelayPlus Thoracic Stent-Graft System
• Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: BOLTON MEDICAL, INC.
• Date Received: 2017-11-17
• Decision Date: 2017-12-08
• PMA: P110038
• Supplement: S016
• 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 Parkway sunrise, FL 33325

Supplemental Filings

Supplement Number	Date	Supplement Type
P110038		Original Filing
S027	2022-12-23	Special (immediate Track)
S026	2022-07-12	30-day Notice
S025	2020-11-24	30-day Notice
S024	2019-09-30	30-day Notice
S023	2019-03-20	30-day Notice
S022
S021
S020	2018-10-05	30-day Notice
S019
S018	2018-05-17	Special (immediate Track)
S017	2017-12-07	Normal 180 Day Track No User Fee
S016	2017-11-17	Special (immediate Track)
S015	2017-04-07	30-day Notice
S014	2016-09-16	30-day Notice
S013	2016-08-29	135 Review Track For 30-day Notice
S012	2016-06-21	Real-time Process
S011	2016-02-22	Real-time Process
S010	2015-10-19	Special (immediate Track)
S009	2015-01-06	Normal 180 Day Track No User Fee
S008	2014-11-14	30-day Notice
S007
S006	2014-09-15	30-day Notice
S005	2014-05-12	30-day Notice
S004	2014-03-24	30-day Notice
S003
S002	2013-06-10	30-day Notice
S001	2012-10-19	Normal 180 Day Track No User Fee

NIH GUDID Devices

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