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 ASD Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | W.L. GORE & ASSOCIATES,INC32360 N North Valley Parkwayphoenix, AZ 85085-1505 PMA NumberP050006 Supplement NumberS104 Date Received11/18/2022 Decision Date12/15/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-11-18 |
| Decision Date | 2022-12-15 |
| PMA | P050006 |
| Supplement | S104 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 NumberS104 Date Received11/18/2022 Decision Date12/15/2022 Product Code MLV Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Minor Modifications To The Instructions For Use And Labeling To Align With ISO 4971:2019 And To Update The Device Storage Conditions |
| 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 |