SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech

Heart-valve, Mechanical

FDA Premarket Approval P810002 S105

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.

Pre-market Approval Supplement Details

Approval for a change to the graphite density specification used for the valve orifice component.

DeviceSJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech
Classification NameHeart-valve, Mechanical
Generic NameHeart-valve, Mechanical
ApplicantSt. Jude Medical, Inc.
Date Received2017-09-08
Decision Date2017-11-16
PMAP810002
SupplementS105
Product CodeLWQ
Docket NumberPremarket 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 CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. one Lillehei Plaza st. Paul, MN 55117

Supplemental Filings

Supplement NumberDateSupplement Type
P810002Original 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

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