GORE CARDIOFORM Septal Occluder

FDA Premarket Approval P050006 S100

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

DeviceGORE CARDIOFORM Septal Occluder
Generic NameTranscatheter Septal Occluder
ApplicantW.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code MLV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-06-06
Decision Date2022-07-06
PMAP050006
SupplementS100
Product CodeMLV 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressW.L. GORE & ASSOCIATES,INC
32360 N North Valley Parkway
phoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code MLV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P050006/S060.

Supplemental Filings

Supplement NumberDateSupplement Type
P050006Original Filing
S100 2022-06-06 Normal 180 Day Track No User Fee
S099 2022-04-28 30-day Notice
S098 2022-01-20 30-day Notice
S097 2022-01-18 30-day Notice
S096 2021-11-19 30-day Notice
S095 2021-10-28 30-day Notice
S094 2021-07-16 30-day Notice
S093
S092 2021-04-06 30-day Notice
S091
S090
S089 2021-01-15 30-day Notice
S088 2021-01-13 30-day Notice
S087 2020-11-24 30-day Notice
S086
S085 2020-07-27 Normal 180 Day Track No User Fee
S084 2020-06-03 Real-time Process
S083 2020-06-02 Special (immediate Track)
S082 2020-03-02 30-day Notice
S081 2019-10-22 30-day Notice
S080 2019-10-02 30-day Notice
S079
S078 2019-06-26 30-day Notice
S077
S076 2019-03-27 30-day Notice
S075 2019-03-12 135 Review Track For 30-day Notice
S074 2019-03-01 30-day Notice
S073 2019-03-01 30-day Notice
S072 2018-12-07 30-day Notice
S071
S070 2018-06-29 30-day Notice
S069 2018-06-01 Normal 180 Day Track
S068 2018-05-24 30-day Notice
S067 2018-04-26 Normal 180 Day Track No User Fee
S066
S065 2018-04-17 30-day Notice
S064 2018-03-20 30-day Notice
S063 2018-03-07 30-day Notice
S062 2018-02-26 30-day Notice
S061 2017-08-29 30-day Notice
S060 2017-07-31 Panel Track
S059 2017-05-17 30-day Notice
S058 2017-02-16 135 Review Track For 30-day Notice
S057
S056 2016-12-09 30-day Notice
S055 2016-11-16 30-day Notice
S054 2016-10-03 30-day Notice
S053 2016-09-26 30-day Notice
S052 2016-09-14 30-day Notice
S051 2016-07-27 30-day Notice
S050 2016-02-26 30-day Notice
S049 2016-01-11 30-day Notice
S048 2015-07-31 30-day Notice
S047 2015-05-14 30-day Notice
S046 2015-02-18 30-day Notice
S045 2015-01-23 30-day Notice
S044 2014-11-03 Normal 180 Day Track
S043 2014-09-29 30-day Notice
S042 2014-06-04 30-day Notice
S041 2014-06-04 30-day Notice
S040 2014-06-04 30-day Notice
S039 2014-06-04 30-day Notice
S038 2014-04-28 30-day Notice
S037 2013-10-22 30-day Notice
S036 2013-07-12 30-day Notice
S035 2013-06-17 Special (immediate Track)
S034 2013-06-05 30-day Notice
S033 2012-11-30 30-day Notice
S032 2012-10-09 30-day Notice
S031 2012-09-05 30-day Notice
S030 2012-08-17 30-day Notice
S029 2012-08-06 135 Review Track For 30-day Notice
S028 2012-05-02 30-day Notice
S027 2012-05-01 30-day Notice
S026 2011-10-20 30-day Notice
S025 2011-10-18 30-day Notice
S024 2011-10-07 30-day Notice
S023 2011-09-30 30-day Notice
S022 2011-09-29 30-day Notice
S021 2011-09-23 30-day Notice
S020 2011-06-16 135 Review Track For 30-day Notice
S019 2011-01-20 30-day Notice
S018 2010-08-17 30-day Notice
S017 2010-07-07 30-day Notice
S016 2010-02-26 Normal 180 Day Track
S015 2009-10-23 30-day Notice
S014 2009-09-17 Normal 180 Day Track
S013 2009-07-23 30-day Notice
S012 2009-06-11 135 Review Track For 30-day Notice
S011 2009-03-17 135 Review Track For 30-day Notice
S010 2009-02-02 30-day Notice
S009 2008-12-19 30-day Notice
S008 2008-05-22 30-day Notice
S007 2008-05-14 30-day Notice
S006 2008-04-07 30-day Notice
S005 2007-11-06 30-day Notice
S004 2007-09-27 135 Review Track For 30-day Notice
S003 2007-04-19 30-day Notice
S002 2006-10-16 Normal 180 Day Track No User Fee
S001 2006-09-12 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
H373HX202534 P050006 037
H373HX201533 P050006 037
H373HX20203 P050006 037
00733132617609 P050006 037
H373HX203535 P050006 037
H373HX203030 P050006 037
00733132631032 P050006 044
00733132631001 P050006 044
00733132631018 P050006 044
00733132631025 P050006 044
00733132636518 P050006 071
00733132636501 P050006 071
00733132636495 P050006 071
00733132636488 P050006 071
00733132636525 P050006 071

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