RelayPlus Thoracic Stent-Graft System

FDA Premarket Approval P110038 S026

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 NumberS026 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-07-12
Decision Date2022-08-11
PMAP110038
SupplementS026
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBOLTON MEDICAL, INC.
799 International Parkway
sunrise, FL 33325 PMA NumberP110038 Supplement NumberS026 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
replacement Of Manufacturing Equipment For A Delivery System Component Of RelayPro And RelayPlus Thoracic Stent-Graft Systems

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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