GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion

FDA Premarket Approval P040027 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

The addition of a camera-based error-proofing mechanism to a machine that manufactures a component of the delivery system

DeviceGORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion
Generic NameShunt, Portosystemic, Endoprosthesis
ApplicantW. L. GORE & ASSOCIATES, INC.
Date Received2020-02-06
Decision Date2020-03-04
PMAP040027
SupplementS078
Product CodeMIR 
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. 32360 N North Valley Parkway phoenix, AZ 85085

Supplemental Filings

Supplement NumberDateSupplement Type
P040027Original Filing
S078 2020-02-06 30-day Notice
S077 2020-01-03 30-day Notice
S076 2019-11-18 30-day Notice
S075 2019-10-25 30-day Notice
S074
S073 2019-04-15 30-day Notice
S072
S071 2019-03-01 30-day Notice
S070 2019-02-19 30-day Notice
S069 2018-12-07 30-day Notice
S068 2018-10-18 30-day Notice
S067 2018-09-18 30-day Notice
S066 2018-08-27 30-day Notice
S065 2018-06-29 30-day Notice
S064 2018-06-07 30-day Notice
S063 2018-06-01 30-day Notice
S062
S061 2018-04-17 30-day Notice
S060 2018-04-16 30-day Notice
S059 2017-09-11 30-day Notice
S058 2017-08-29 30-day Notice
S057 2017-05-26 30-day Notice
S056 2017-05-12 30-day Notice
S055
S054 2017-01-18 Real-time Process
S053 2016-12-12 30-day Notice
S052 2016-11-07 Special (immediate Track)
S051 2016-10-03 30-day Notice
S050 2016-09-06 30-day Notice
S049 2016-08-25 30-day Notice
S048 2016-02-22 Normal 180 Day Track
S047 2015-12-08 30-day Notice
S046 2015-11-16 30-day Notice
S045 2015-07-21 30-day Notice
S044 2015-05-14 30-day Notice
S043 2015-05-05 30-day Notice
S042 2015-04-30 30-day Notice
S041 2015-03-04 30-day Notice
S040 2015-02-18 30-day Notice
S039 2014-11-28 30-day Notice
S038 2014-09-29 30-day Notice
S037 2014-06-04 30-day Notice
S036 2014-06-04 30-day Notice
S035 2014-06-04 30-day Notice
S034 2014-06-04 30-day Notice
S033 2014-04-28 30-day Notice
S032 2013-09-16 30-day Notice
S031 2013-07-12 30-day Notice
S030 2013-04-17 30-day Notice
S029 2013-04-02 30-day Notice
S028 2012-05-01 30-day Notice
S027
S026 2011-10-07 30-day Notice
S025 2011-09-30 30-day Notice
S024 2011-03-24 Normal 180 Day Track No User Fee
S023
S022 2010-08-02 30-day Notice
S021 2010-08-02 30-day Notice
S020 2010-07-07 30-day Notice
S019 2010-02-12 135 Review Track For 30-day Notice
S018 2009-10-23 30-day Notice
S017 2009-08-25 30-day Notice
S016 2009-07-02 30-day Notice
S015 2009-06-19 30-day Notice
S014 2009-03-18 30-day Notice
S013 2009-02-02 30-day Notice
S012 2008-03-03 30-day Notice
S011 2008-02-26 30-day Notice
S010 2008-01-22 135 Review Track For 30-day Notice
S009 2007-12-07 135 Review Track For 30-day Notice
S008 2007-11-06 30-day Notice
S007 2007-09-12 Real-time Process
S006 2007-08-24 30-day Notice
S005 2007-05-15 30-day Notice
S004 2007-04-02 30-day Notice
S003 2006-10-12 Special (immediate Track)
S002 2005-09-19 135 Review Track For 30-day Notice
S001 2004-12-16 30-day Notice

NIH GUDID Devices

Device IDPMASupp
H373PTB0842753 P040027 033
H373PTB0872753 P040027 033
H373PTB0862753 P040027 033
H373PTB0852753 P040027 033
H373PTB0842753 P040027 033
00733132609796 P040027 033
00733132609802 P040027 033
00733132609819 P040027 033
00733132609826 P040027 033
00733132609833 P040027 033
00733132609864 P040027 033
00733132609857 P040027 033
H373PTB0882753 P040027 033
00733132609796 P040027 033
H373PTB0852753 P040027 033
H373PTB0862753 P040027 033
H373PTB0872753 P040027 033
H373PTB0882753 P040027 033
00733132609864 P040027 033
00733132609857 P040027 033
00733132609840 P040027 033
00733132609833 P040027 033
00733132609826 P040027 033
00733132609819 P040027 033
00733132609802 P040027 033
00733132609840 P040027 033
00733132635009 P040027 048
00733132635030 P040027 048
00733132635023 P040027 048
00733132635016 P040027 048
00733132635009 P040027 048
00733132635047 P040027 048
00733132635030 P040027 048
00733132635023 P040027 048
00733132635016 P040027 048
00733132635047 P040027 048

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