Mechanical Heart Valve

FDA Premarket Approval P810002 S111

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

An alternative bet batch sampling plan

DeviceMechanical Heart Valve
Generic NameHeart-valve, Mechanical
ApplicantSt. Jude Medical, Inc.
Date Received2020-04-28
Decision Date2020-05-12
PMAP810002
SupplementS111
Product CodeLWQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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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