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.
Approval for an increase of the orifice lot sizes during the pyrolytic carbon coating process at the woodrige manufacturing facility.
| Device | ST. JUDE MEDICAL MECHANICAL HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 1997-05-05 |
| Decision Date | 1999-10-21 |
| PMA | P810002 |
| Supplement | S045 |
| Product Code | LWQ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |