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 | Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield™ graft technology (C |
Generic Name | Heart-valve, Mechanical |
Applicant | Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP810002 Supplement NumberS116 Date Received12/28/2022 Decision Date01/27/2023 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-12-28 |
Decision Date | 2023-01-27 |
PMA | P810002 |
Supplement | S116 |
Product Code | LWQ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Abbott Medical 177 County Road B. East st. Paul, MN 55117 PMA NumberP810002 Supplement NumberS116 Date Received12/28/2022 Decision Date01/27/2023 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change To The Supplier Of Resin Material Used In Manufacturing Mechanical Heart Valve Fabric And Conduit Components |
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 |