RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P110038 S014

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

Use of an automatic drilling machine in the manufacture of the rotator body component of the relay thoracic stent-graft plus delivery system.

DeviceRELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBOLTON MEDICAL, INC.
Date Received2016-09-16
Decision Date2016-10-13
PMAP110038
SupplementS014
Product CodeMIH
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOLTON MEDICAL, INC. 799 International Parkway sunrise, FL 33325

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

Device IDPMASupp
00843576102262 P110038 000
00843576102422 P110038 000
00843576102439 P110038 000
00843576102446 P110038 000
00843576102453 P110038 000
08426950562856 P110038 000
08426950562863 P110038 000
08426950562870 P110038 000
08426950562887 P110038 000
08426950562894 P110038 000
08426950562900 P110038 000
08426950562917 P110038 000
08426950562924 P110038 000
08426950562931 P110038 000
00843576102415 P110038 000
00843576102408 P110038 000
00843576102279 P110038 000
00843576102286 P110038 000
00843576102293 P110038 000
00843576102309 P110038 000
00843576102316 P110038 000
00843576102323 P110038 000
00843576102330 P110038 000
00843576102347 P110038 000
00843576102354 P110038 000
00843576102361 P110038 000
00843576102378 P110038 000
00843576102385 P110038 000
00843576102392 P110038 000
08426950562948 P110038 000
08426950562955 P110038 000
08426950562962 P110038 000
08426950563150 P110038 000
08426950563167 P110038 000
08426950563174 P110038 000
08426950563181 P110038 000
08426950563198 P110038 000
08426950563204 P110038 000
08426950563211 P110038 000
08426950563228 P110038 000
08426950563235 P110038 000
08426950563242 P110038 000
08426950563259 P110038 000
08426950563266 P110038 000
08426950563273 P110038 000
08426950563143 P110038 000
08426950563136 P110038 000
08426950562979 P110038 000
08426950562986 P110038 000
08426950562993 P110038 000
08426950563006 P110038 000
08426950563013 P110038 000
08426950563020 P110038 000
08426950563037 P110038 000
08426950563044 P110038 000
08426950563082 P110038 000
08426950563099 P110038 000
08426950563105 P110038 000
08426950563112 P110038 000
08426950563129 P110038 000
08426950563280 P110038 000
00843576102255 P110038 000
00843576101647 P110038 000
00843576101807 P110038 000
00843576101814 P110038 000
00843576101821 P110038 000
00843576101838 P110038 000
00843576101845 P110038 000
00843576101852 P110038 000
00843576101869 P110038 000
00843576101876 P110038 000
00843576101883 P110038 000
00843576101890 P110038 000
00843576101906 P110038 000
00843576101913 P110038 000
00843576101920 P110038 000
00843576101791 P110038 000
00843576101784 P110038 000
00843576101654 P110038 000
00843576101661 P110038 000
00843576101678 P110038 000
00843576101685 P110038 000
00843576101692 P110038 000
00843576101708 P110038 000
00843576101715 P110038 000
00843576101722 P110038 000
00843576101739 P110038 000
00843576101746 P110038 000
00843576101753 P110038 000
00843576101760 P110038 000
00843576101777 P110038 000
00843576101937 P110038 000
00843576101944 P110038 000
00843576101951 P110038 000
00843576102118 P110038 000
00843576102125 P110038 000
00843576102132 P110038 000
00843576102149 P110038 000
00843576102156 P110038 000
00843576102163 P110038 000
00843576102170 P110038 000
00843576102187 P110038 000
00843576102194 P110038 000
00843576102200 P110038 000
00843576102217 P110038 000
00843576102224 P110038 000
00843576102231 P110038 000
00843576102101 P110038 000
00843576102095 P110038 000
00843576101968 P110038 000
00843576101975 P110038 000
00843576101982 P110038 000
00843576101999 P110038 000
00843576102002 P110038 000
00843576102019 P110038 000
00843576102026 P110038 000
00843576102033 P110038 000
00843576102040 P110038 000
00843576102057 P110038 000
00843576102064 P110038 000
00843576102071 P110038 000
00843576102088 P110038 000
00843576102248 P110038 000
08435761001850 P110038 000
08435761002017 P110038 000
08435761002024 P110038 000
08435761002031 P110038 000
08435761002048 P110038 000
08435761002055 P110038 000
08435761002062 P110038 000
08435761002079 P110038 000
08435761002086 P110038 000
08435761002093 P110038 000
08435761002109 P110038 000
08435761002116 P110038 000
08435761002123 P110038 000
08435761002130 P110038 000
08435761002000 P110038 000
08435761001997 P110038 000
08435761001867 P110038 000
08435761001874 P110038 000
08435761001881 P110038 000
08435761001898 P110038 000
08435761001904 P110038 000
08435761001911 P110038 000
08435761001928 P110038 000
08435761001935 P110038 000
08435761001942 P110038 000
08435761001959 P110038 000
08435761001966 P110038 000
08435761001973 P110038 000
08435761001980 P110038 000
08435761002147 P110038 000
08435761002154 P110038 000
08435761002161 P110038 000
08435761002321 P110038 000
08435761002338 P110038 000
08435761002345 P110038 000
08435761002352 P110038 000
08435761002369 P110038 000
08435761002376 P110038 000
08435761002383 P110038 000
08435761002390 P110038 000
08435761002406 P110038 000
08435761002413 P110038 000
08435761002420 P110038 000
08435761002437 P110038 000
08435761002444 P110038 000
08435761002314 P110038 000
08435761002307 P110038 000
08435761002178 P110038 000
08435761002185 P110038 000
08435761002192 P110038 000
08435761002208 P110038 000
08435761002215 P110038 000
08435761002222 P110038 000
08435761002239 P110038 000
08435761002246 P110038 000
08435761002253 P110038 000
08435761002260 P110038 000
08435761002277 P110038 000
08435761002284 P110038 000
08435761002291 P110038 000
08435761002451 P110038 000
08435761001843 P110038 000
08426950563297 P110038 000
08426950563457 P110038 000
08426950563464 P110038 000
08426950563471 P110038 000
08426950563488 P110038 000
08426950563495 P110038 000
08426950563501 P110038 000
08426950563518 P110038 000
08426950563525 P110038 000
08426950563532 P110038 000
08426950563549 P110038 000
08426950563556 P110038 000
08426950563563 P110038 000
08426950563570 P110038 000
08426950563440 P110038 000
08426950563433 P110038 000
08426950563303 P110038 000
08426950563310 P110038 000
08426950563327 P110038 000
08426950563334 P110038 000
08426950563341 P110038 000
08426950563358 P110038 000
08426950563365 P110038 000
08426950563372 P110038 000
08426950563389 P110038 000
08426950563396 P110038 000
08426950563402 P110038 000
08426950563419 P110038 000
08426950563426 P110038 000
08426950563587 P110038 000
08426950563594 P110038 000
08426950563600 P110038 000
08435761001706 P110038 000
08435761001713 P110038 000
08435761001720 P110038 000
08435761001737 P110038 000
08435761001744 P110038 000
08435761001751 P110038 000
08435761001768 P110038 000
08435761001775 P110038 000
08435761001782 P110038 000
08435761001799 P110038 000
08435761001805 P110038 000
08435761001812 P110038 000
08435761001829 P110038 000
08435761001690 P110038 000
08435761001683 P110038 000
08426950563617 P110038 000
08426950563624 P110038 000
08426950563631 P110038 000
08426950563648 P110038 000
08426950563655 P110038 000
08426950563662 P110038 000
08426950563679 P110038 000
08426950563686 P110038 000
08426950563693 P110038 000
08435761001645 P110038 000
08435761001652 P110038 000
08435761001669 P110038 000
08435761001676 P110038 000
08435761001836 P110038 000
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.