RelayPlus Thoracic Stent-Graft System

FDA Premarket Approval P110038 S027

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: RelayPlus Thoracic Stent-Graft System
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: BOLTON MEDICAL, INC.799 International Parkwaysunrise, FL 33325 PMA NumberP110038 Supplement NumberS027 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: P110038
• Supplement: S027
• 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 PMA NumberP110038 Supplement NumberS027 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
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

Device ID	PMA	Supp
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