P960004S037

None

FDA Premarket Approval P960004 S037

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

DeviceP960004S037
Classification NameNone
Applicant
PMAP960004
SupplementS037

Supplemental Filings

Supplement NumberDateSupplement Type
P960004Original Filing
S101 2022-11-01 30-day Notice
S100 2022-07-26 30-day Notice
S099 2022-02-23 30-day Notice
S098 2021-09-30 30-day Notice
S097 2021-09-30 30-day Notice
S096 2021-09-23 30-day Notice
S095 2021-09-01 30-day Notice
S094 2021-04-30 30-day Notice
S093 2021-03-08 30-day Notice
S092 2021-01-11 30-day Notice
S091 2020-09-02 30-day Notice
S090 2019-05-03 Normal 180 Day Track
S089 2019-03-13 30-day Notice
S088 2018-12-26 Real-time Process
S087 2018-12-20 30-day Notice
S086 2018-07-13 30-day Notice
S085 2018-04-30 Normal 180 Day Track
S084 2018-04-25 30-day Notice
S083 2018-03-26 30-day Notice
S082 2018-01-11 30-day Notice
S081 2017-05-26 Normal 180 Day Track
S080 2017-04-26 30-day Notice
S079 2017-03-30 30-day Notice
S078 2016-12-09 Normal 180 Day Track
S077 2016-07-07 30-day Notice
S076 2016-05-27 30-day Notice
S075 2015-11-20 135 Review Track For 30-day Notice
S074 2015-09-17 30-day Notice
S073 2015-09-01 30-day Notice
S072 2015-07-21 30-day Notice
S071
S070 2015-06-22 30-day Notice
S069 2015-06-05 30-day Notice
S068 2015-04-20 30-day Notice
S067 2014-11-25 30-day Notice
S066 2014-06-30 30-day Notice
S065 2014-04-22 30-day Notice
S064 2013-11-08 30-day Notice
S063 2013-08-29 30-day Notice
S062
S061 2013-05-16 Real-time Process
S060 2013-06-26 Normal 180 Day Track
S059 2013-03-27 Normal 180 Day Track
S058 2012-11-08 30-day Notice
S057 2012-10-02 30-day Notice
S056 2012-09-10 30-day Notice
S055 2012-09-04 30-day Notice
S054 2012-07-26 Real-time Process
S053 2012-06-19 Real-time Process
S052 2012-06-18 30-day Notice
S051 2012-03-26 30-day Notice
S050 2012-01-24 30-day Notice
S049 2011-04-01 30-day Notice
S048 2011-02-22 30-day Notice
S047
S046 2010-08-23 30-day Notice
S045 2009-12-18 30-day Notice
S044 2009-12-16 30-day Notice
S043
S042 2008-12-08 Real-time Process
S041 2008-08-25 Real-time Process
S040
S039 2007-03-19 Real-time Process
S038 2006-08-01 135 Review Track For 30-day Notice
S037
S036 2006-04-13 30-day Notice
S035 2006-04-13 30-day Notice
S034 2006-02-09 30-day Notice
S033
S032 2005-12-22 30-day Notice
S031 2005-12-22 30-day Notice
S030 2005-12-22 30-day Notice
S029 2005-12-20 30-day Notice
S028 2005-02-24 30-day Notice
S027 2004-12-03 30-day Notice
S026 2004-10-21 30-day Notice
S025 2004-04-14 30-day Notice
S024 2004-01-13 30-day Notice
S023 2003-12-03 Special (immediate Track)
S022 2003-06-03 30-day Notice
S021 2002-11-13 30-day Notice
S020 2001-11-16 Real-time Process
S019 2001-10-04 Real-time Process
S018 2001-02-20 Real-time Process
S017 2000-12-26 Normal 180 Day Track
S016
S015 2000-08-21 Normal 180 Day Track
S014 2000-05-26 Normal 180 Day Track
S013 2000-05-15 Normal 180 Day Track
S012 2000-05-15 30-day Notice
S011 2000-01-11 Real-time Process
S010 1999-09-14 Normal 180 Day Track
S009 1999-10-25 Normal 180 Day Track
S008 1999-08-31 Normal 180 Day Track
S007 1999-08-31 135 Review Track For 30-day Notice
S006 1999-06-23 Normal 180 Day Track
S005 1999-06-14 Real-time Process
S004
S003
S002 1997-04-17 Normal 180 Day Track
S001 1997-01-27 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00802526488825 P960004 011
00802526488986 P960004 011
00802526488979 P960004 011
00802526488962 P960004 011
00802526488955 P960004 011
00802526488948 P960004 011
00802526488931 P960004 011
00802526488924 P960004 011
00802526488917 P960004 011
00802526488900 P960004 011
00802526488894 P960004 011
00802526488887 P960004 011
00802526488870 P960004 011
00802526488863 P960004 011
00802526488856 P960004 011
00802526488849 P960004 011
00802526488832 P960004 011
00802526488993 P960004 011
00802526489006 P960004 011
00802526489013 P960004 011
00802526489150 P960004 011
00802526489143 P960004 011
00802526489136 P960004 011
00802526489129 P960004 011
00802526489112 P960004 011
00802526489105 P960004 011
00802526489099 P960004 011
00802526489082 P960004 011
00802526489075 P960004 011
00802526489068 P960004 011
00802526489051 P960004 011
00802526489044 P960004 011
00802526489037 P960004 011
00802526489020 P960004 011
00802526489341 P960004 011
00802526489181 P960004 019
00802526489167 P960004 019
00802526264993 P960004 022
00802526265006 P960004 022
00802526265013 P960004 022
00802526265020 P960004 022
00802526265037 P960004 022
00802526265143 P960004 022
00802526087752 P960004 039
00802526061974 P960004 039
00802526061936 P960004 039
00802526061004 P960004 039
00802526060953 P960004 039
00802526060915 P960004 039

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