GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

FDA Premarket Approval P130006 S074

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

Changing an analytical testing laboratory site

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 Received2020-01-03
Decision Date2020-01-23
PMAP130006
SupplementS074
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
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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