GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

FDA Premarket Approval P130006 S078

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

A change to knitting process equipment for a delivery system component

DeviceGORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Generic NameSystem, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment
ApplicantW.L. GORE & ASSOCIATES,INC
Date Received2020-06-16
Decision Date2020-07-15
PMAP130006
SupplementS078
Product CodePFV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address W.L. GORE & ASSOCIATES,INC 3250 W.kiltie Lane flagstaff, AZ 86001

Supplemental Filings

Supplement NumberDateSupplement Type
P130006Original Filing
S078 2020-06-16 30-day Notice
S077 2020-05-07 30-day Notice
S076 2020-05-04 30-day Notice
S075 2020-02-06 30-day Notice
S074 2020-01-03 30-day Notice
S073
S072 2019-08-22 Real-time Process
S071 2019-04-15 30-day Notice
S070 2019-03-20 30-day Notice
S069
S068 2019-03-01 30-day Notice
S067 2019-02-19 30-day Notice
S066 2019-02-04 30-day Notice
S065 2019-01-15 30-day Notice
S064 2018-12-07 30-day Notice
S063 2018-11-15 30-day Notice
S062 2018-11-06 Normal 180 Day Track
S061 2018-09-18 30-day Notice
S060 2018-08-27 30-day Notice
S059 2018-08-24 30-day Notice
S058 2018-07-26 30-day Notice
S057 2018-06-29 30-day Notice
S056 2018-06-07 30-day Notice
S055 2018-06-01 30-day Notice
S054 2018-05-25 30-day Notice
S053 2018-05-03 30-day Notice
S052
S051 2018-04-17 30-day Notice
S050 2018-02-20 30-day Notice
S049 2018-02-06 30-day Notice
S048 2018-01-23 30-day Notice
S047 2017-12-05 30-day Notice
S046 2017-11-03 30-day Notice
S045 2017-10-16 30-day Notice
S044 2017-10-11 135 Review Track For 30-day Notice
S043 2017-09-11 30-day Notice
S042 2017-08-29 30-day Notice
S041 2017-08-23 30-day Notice
S040 2017-08-15 30-day Notice
S039 2017-07-05 30-day Notice
S038 2017-05-26 30-day Notice
S037
S036 2016-12-09 30-day Notice
S035 2016-11-18 30-day Notice
S034 2016-11-08 30-day Notice
S033 2016-10-03 30-day Notice
S032 2016-08-25 30-day Notice
S031 2016-05-17 30-day Notice
S030 2016-04-18 Normal 180 Day Track No User Fee
S029 2016-03-09 30-day Notice
S028 2016-02-03 30-day Notice
S027 2016-01-06 30-day Notice
S026 2015-11-09 30-day Notice
S025 2015-11-02 30-day Notice
S024 2015-07-21 30-day Notice
S023 2015-07-06 30-day Notice
S022 2015-07-01 30-day Notice
S021 2015-07-01 30-day Notice
S020 2015-06-15 Normal 180 Day Track No User Fee
S019 2015-05-14 30-day Notice
S018 2015-05-04 30-day Notice
S017
S016 2015-04-13 30-day Notice
S015 2014-10-23 30-day Notice
S014 2014-10-14 Real-time Process
S013 2014-09-29 30-day Notice
S012 2014-09-24 30-day Notice
S011 2014-09-19 30-day Notice
S010 2014-07-01 30-day Notice
S009 2014-06-04 30-day Notice
S008 2014-06-04 30-day Notice
S007 2014-06-04 30-day Notice
S006 2014-06-04 30-day Notice
S005 2014-05-23 30-day Notice
S004 2014-05-19 30-day Notice
S003 2014-04-28 30-day Notice
S002 2014-02-18 Real-time Process
S001 2014-02-18 Real-time Process

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