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.
This supplement requested approval for labeling changes specific for each valve configuration in a precaution statement in the instructions for use.
| Device | Masters Mechanical Heart Valve |
| Generic Name | Heart-valve, Mechanical |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2021-07-23 |
| Decision Date | 2021-08-19 |
| PMA | P810002 |
| Supplement | S113 |
| Product Code | LWQ |
| 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 | St. Jude Medical, Inc. one Lillehei Plaza st. Paul, MN 55117 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810002 | Original Filing | |
| S116 | 2022-12-28 | 30-day Notice |
| S115 | 2021-11-10 | 30-day Notice |
| S114 | 2021-09-20 | 30-day Notice |
| S113 | 2021-07-23 | Special (immediate Track) |
| S112 | 2020-05-05 | 30-day Notice |
| S111 | 2020-04-28 | 30-day Notice |
| S110 | ||
| S109 | 2019-02-27 | 30-day Notice |
| S108 | ||
| S107 | 2018-04-09 | Normal 180 Day Track No User Fee |
| S106 | 2018-02-01 | 30-day Notice |
| S105 | 2017-09-08 | Real-time Process |
| S104 | ||
| S103 | 2017-07-19 | 30-day Notice |
| S102 | ||
| S101 | 2017-06-21 | Normal 180 Day Track |
| S100 | 2016-12-30 | 30-day Notice |
| S099 | 2016-11-28 | 30-day Notice |
| S098 | 2016-09-29 | Real-time Process |
| S097 | 2016-03-29 | 30-day Notice |
| S096 | 2015-03-10 | 30-day Notice |
| S095 | 2015-02-25 | 30-day Notice |
| S094 | 2015-01-20 | 30-day Notice |
| S093 | 2015-01-12 | 30-day Notice |
| S092 | 2014-11-21 | 30-day Notice |
| S091 | 2014-11-12 | 30-day Notice |
| S090 | 2014-05-19 | 135 Review Track For 30-day Notice |
| S089 | 2014-03-10 | 30-day Notice |
| S088 | 2013-12-03 | 30-day Notice |
| S087 | 2013-07-05 | 30-day Notice |
| S086 | 2013-05-28 | 30-day Notice |
| S085 | 2013-04-30 | 30-day Notice |
| S084 | 2013-04-04 | 135 Review Track For 30-day Notice |
| S083 | 2012-06-28 | 30-day Notice |
| S082 | 2012-03-13 | 135 Review Track For 30-day Notice |
| S081 | 2012-02-29 | 30-day Notice |
| S080 | 2012-02-07 | Normal 180 Day Track No User Fee |
| S079 | 2012-02-01 | 30-day Notice |
| S078 | 2011-08-17 | Real-time Process |
| S077 | 2011-07-05 | 135 Review Track For 30-day Notice |
| S076 | 2011-06-13 | Real-time Process |
| S075 | ||
| S074 | 2011-02-16 | 135 Review Track For 30-day Notice |
| S073 | 2011-02-16 | 30-day Notice |
| S072 | 2010-12-02 | 30-day Notice |
| S071 | 2010-06-02 | 30-day Notice |
| S070 | 2009-04-15 | 30-day Notice |
| S069 | 2009-03-09 | Normal 180 Day Track No User Fee |
| S068 | 2008-10-14 | Real-time Process |
| S067 | 2008-07-03 | Real-time Process |
| S066 | 2008-06-17 | 30-day Notice |
| S065 | 2008-06-03 | Normal 180 Day Track No User Fee |
| S064 | 2008-04-14 | 30-day Notice |
| S063 | 2008-02-25 | Normal 180 Day Track No User Fee |
| S062 | 2007-09-13 | 135 Review Track For 30-day Notice |
| S061 | 2006-11-21 | Real-time Process |
| S060 | 2006-10-23 | 135 Review Track For 30-day Notice |
| S059 | 2006-03-31 | Real-time Process |
| S058 | 2005-01-03 | Real-time Process |
| S057 | 2001-09-07 | Normal 180 Day Track |
| S056 | 2001-03-26 | Real-time Process |
| S055 | 2001-01-29 | Normal 180 Day Track |
| S054 | 2000-09-27 | Real-time Process |
| S053 | 2000-07-28 | Normal 180 Day Track |
| S052 | 2000-05-22 | Normal 180 Day Track |
| S051 | 2000-04-12 | Real-time Process |
| S050 | 1999-09-22 | Normal 180 Day Track |
| S049 | 1999-02-09 | Normal 180 Day Track |
| S048 | 1998-11-04 | Normal 180 Day Track |
| S047 | 1998-06-26 | 30-day Notice |
| S046 | 1997-05-15 | Normal 180 Day Track |
| S045 | 1997-05-05 | Normal 180 Day Track |
| S044 | 1997-04-23 | Normal 180 Day Track |
| S043 | 1997-02-27 | Normal 180 Day Track |
| S042 | 1996-04-17 | Special (immediate Track) |
| S041 | 1996-03-07 | Normal 180 Day Track |
| S040 | 1995-09-11 | Normal 180 Day Track |
| S039 | 1995-09-11 | Normal 180 Day Track |
| S038 | 1995-08-15 | Normal 180 Day Track |
| S037 | 1995-07-03 | Special (immediate Track) |
| S036 | 1995-05-05 | Normal 180 Day Track |
| S035 | 1995-02-03 | Normal 180 Day Track |
| S034 | 1994-12-12 | Normal 180 Day Track |
| S033 | 1994-12-09 | Normal 180 Day Track |
| S032 | 1994-06-24 | Normal 180 Day Track |
| S031 | ||
| S030 | 1994-03-16 | Normal 180 Day Track |
| S029 | 1994-03-02 | Normal 180 Day Track |
| S028 | 1994-03-02 | Normal 180 Day Track |
| S027 | 1993-07-15 | Normal 180 Day Track |
| S026 | 1993-07-01 | Normal 180 Day Track |
| S025 | 1993-01-04 | Normal 180 Day Track |
| S024 | 1992-04-17 | Normal 180 Day Track |
| S023 | ||
| S022 | 1991-09-20 | Normal 180 Day Track |
| S021 | 1991-05-06 | Normal 180 Day Track |
| S020 | 1990-12-17 | Special (immediate Track) |
| S019 | 1990-06-26 | Normal 180 Day Track |
| S018 | 1988-06-15 | Normal 180 Day Track |
| S017 | 1988-05-25 | Normal 180 Day Track |
| S016 | 1987-12-31 | Special (immediate Track) |
| S015 | 1987-11-23 | Normal 180 Day Track |
| S014 | 1987-11-13 | Normal 180 Day Track |
| S013 | 1987-05-04 | Normal 180 Day Track |
| S012 | 1986-12-23 | Normal 180 Day Track |
| S011 | 1986-12-22 | Special (immediate Track) |
| S010 | 1986-08-27 | Normal 180 Day Track |
| S009 | 1986-07-23 | Normal 180 Day Track |
| S008 | 1986-06-14 | Normal 180 Day Track |
| S007 | ||
| S006 | 1984-07-27 | |
| S005 | ||
| S004 | 1984-01-27 | |
| S003 | 1983-04-11 | |
| S002 | 1983-03-17 | |
| S001 | 1983-02-28 |