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.
| Device | GORE CARDIOFORM Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | W.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 Received | 2022-06-06 |
| Decision Date | 2022-07-06 |
| PMA | P050006 |
| Supplement | S100 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W.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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050006 | Original Filing | |
| S105 | 2022-12-15 | 30-day Notice |
| S104 | 2022-11-18 | Special (immediate Track) |
| S103 | ||
| S102 | 2022-09-09 | 30-day Notice |
| S101 | ||
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |