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

DeviceRelayPlus Thoracic Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBOLTON 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 Received2022-12-23
Decision Date2023-01-20
PMAP110038
SupplementS027
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressBOLTON 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 NumberDateSupplement Type
P110038Original 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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