P950037S202

None

FDA Premarket Approval P950037 S202

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

DeviceP950037S202
Classification NameNone
Applicant
PMAP950037
SupplementS202

Supplemental Filings

Supplement NumberDateSupplement Type
P950037Original Filing
S205 2019-09-17 30-day Notice
S204 2019-08-15 Real-time Process
S203 2019-06-20 30-day Notice
S202
S201 2019-04-23 30-day Notice
S200
S199 2018-12-10 Normal 180 Day Track No User Fee
S198 2018-11-01 Normal 180 Day Track
S197 2018-09-12 Normal 180 Day Track
S196 2018-09-04 30-day Notice
S195 2018-08-22 Real-time Process
S194 2018-07-13 Normal 180 Day Track
S193 2018-07-10 30-day Notice
S192 2018-06-14 135 Review Track For 30-day Notice
S191 2018-05-18 30-day Notice
S190 2018-05-17 Real-time Process
S189 2018-05-14 30-day Notice
S188
S187 2018-02-23 135 Review Track For 30-day Notice
S186 2018-02-09 Normal 180 Day Track
S185 2018-01-22 30-day Notice
S184 2017-11-20 30-day Notice
S183 2017-11-20 Real-time Process
S182 2017-10-18 Real-time Process
S181 2017-08-23 Real-time Process
S180 2017-08-14 30-day Notice
S179 2017-06-06 Real-time Process
S178 2017-06-02 30-day Notice
S177 2017-05-24 Real-time Process
S176 2017-05-05 Real-time Process
S175 2017-04-20 Real-time Process
S174 2017-04-12 Real-time Process
S173 2017-02-16 Normal 180 Day Track
S172 2017-01-03 30-day Notice
S171 2016-12-07 Normal 180 Day Track
S170 2016-11-21 30-day Notice
S169 2016-11-21 Real-time Process
S168 2016-09-23 30-day Notice
S167 2016-08-08 Normal 180 Day Track
S166 2016-07-28 Normal 180 Day Track
S165 2016-06-09 Real-time Process
S164 2016-06-06 Normal 180 Day Track
S163 2016-05-31 30-day Notice
S162 2016-03-24 Real-time Process
S161 2015-12-23 Normal 180 Day Track
S160 2015-12-16 Real-time Process
S159
S158 2015-08-03 30-day Notice
S157 2015-06-09 30-day Notice
S156 2015-06-01 Normal 180 Day Track
S155 2015-05-27 30-day Notice
S154 2015-05-19 30-day Notice
S153 2015-04-29 135 Review Track For 30-day Notice
S152 2015-04-16 30-day Notice
S151 2015-04-16 Normal 180 Day Track
S150 2015-03-23 Normal 180 Day Track
S149 2015-03-06 135 Review Track For 30-day Notice
S148 2015-02-13 Real-time Process
S147 2015-02-04 30-day Notice
S146 2015-01-08 30-day Notice
S145 2014-11-03 30-day Notice
S144 2014-10-31 30-day Notice
S143 2014-10-14 30-day Notice
S142 2014-09-25 Normal 180 Day Track
S141 2014-09-24 30-day Notice
S140 2014-09-19 30-day Notice
S139 2014-08-04 Normal 180 Day Track
S138 2014-07-28 Normal 180 Day Track
S137 2014-06-23 Normal 180 Day Track
S136 2014-06-23 30-day Notice
S135 2014-06-13 Real-time Process
S134 2014-05-30 30-day Notice
S133 2013-12-09 30-day Notice
S132 2013-11-25 Normal 180 Day Track
S131 2013-11-07 Real-time Process
S130 2013-11-05 30-day Notice
S129 2013-11-05 30-day Notice
S128 2013-08-15 Real-time Process
S127 2013-07-29 Real-time Process
S126 2013-07-16 30-day Notice
S125 2013-06-03 Real-time Process
S124 2013-05-20 Real-time Process
S123 2013-04-29 30-day Notice
S122 2013-04-22 30-day Notice
S121 2013-04-03 Real-time Process
S120
S119 2013-02-05 Real-time Process
S118 2013-01-14 30-day Notice
S117 2012-12-21 Real-time Process
S116 2012-12-18 Normal 180 Day Track
S115
S114 2012-12-03 30-day Notice
S113 2012-11-19 Real-time Process
S112 2012-09-07 30-day Notice
S111 2012-08-10 Real-time Process
S110 2012-07-02 Real-time Process
S109 2012-06-18 Real-time Process
S108 2012-04-05 Real-time Process
S107 2012-04-02 135 Review Track For 30-day Notice
S106
S105 2012-03-01 Normal 180 Day Track
S104 2012-02-17 Real-time Process
S103 2012-02-06 30-day Notice
S102 2012-01-30 Real-time Process
S101 2012-01-27 Real-time Process
S100 2011-11-02 Normal 180 Day Track
S099 2011-10-03 Real-time Process
S098 2011-08-19 Normal 180 Day Track
S097 2011-06-16 135 Review Track For 30-day Notice
S096 2011-04-11 Real-time Process
S095 2011-03-23 30-day Notice
S094 2011-03-10 30-day Notice
S093
S092 2010-12-13 Real-time Process
S091 2010-12-10 Normal 180 Day Track
S090 2010-11-09 30-day Notice
S089 2010-10-28 Normal 180 Day Track
S088 2010-10-06 Normal 180 Day Track
S087
S086 2010-08-20 30-day Notice
S085 2010-08-12 30-day Notice
S084 2010-07-14 Normal 180 Day Track
S083 2010-06-08 Normal 180 Day Track
S082 2010-05-28 Normal 180 Day Track No User Fee
S081 2010-05-11 Real-time Process
S080 2010-04-13 30-day Notice
S079 2010-03-23 Normal 180 Day Track
S078 2010-03-02 Real-time Process
S077 2010-02-12 30-day Notice
S076 2009-11-25 Real-time Process
S075
S074 2009-11-24 Real-time Process
S073 2009-09-10 Real-time Process
S072 2009-07-08 Normal 180 Day Track
S071 2009-03-23 Real-time Process
S070 2009-03-06 30-day Notice
S069 2009-02-13 Real-time Process
S068 2009-01-26 Normal 180 Day Track
S067 2008-11-17 Normal 180 Day Track
S066 2008-10-31 Real-time Process
S065 2008-10-17 Real-time Process
S064 2008-10-17 Real-time Process
S063 2008-09-05 30-day Notice
S062 2008-06-04 135 Review Track For 30-day Notice
S061 2008-05-21 Real-time Process
S060 2008-05-14 Real-time Process
S059 2008-05-14 Normal 180 Day Track
S058 2008-03-18 Real-time Process
S057 2008-02-04 Normal 180 Day Track
S056 2008-01-07 Real-time Process
S055 2007-10-23 Real-time Process
S054 2007-08-13 Normal 180 Day Track
S053 2007-07-13 Normal 180 Day Track
S052 2007-06-25 30-day Notice
S051 2007-04-10 Real-time Process
S050 2007-01-22 Real-time Process
S049 2007-01-11 Real-time Process
S048 2006-12-13 Real-time Process
S047 2006-10-12 Real-time Process
S046 2006-09-11 Normal 180 Day Track
S045 2006-06-29 Real-time Process
S044 2006-04-10 135 Review Track For 30-day Notice
S043 2006-02-24 Real-time Process
S042 2005-11-09 Normal 180 Day Track
S041 2005-09-26 Real-time Process
S040
S039 2004-08-09 Normal 180 Day Track
S038 2004-05-27 Normal 180 Day Track
S037 2004-02-12 Real-time Process
S036 2003-11-03 Normal 180 Day Track
S035 2003-07-28 Normal 180 Day Track
S034 2003-07-14 Normal 180 Day Track
S033 2003-06-24 Normal 180 Day Track
S032 2003-02-28 Normal 180 Day Track
S031 2003-02-06 Real-time Process
S030 2003-01-09 Normal 180 Day Track
S029 2002-11-20 30-day Notice
S028 2002-11-15 Real-time Process
S027
S026
S025
S024 2001-12-31 Normal 180 Day Track
S023 2002-02-11 Normal 180 Day Track
S022 2001-09-28 Real-time Process
S021 2001-07-27 Normal 180 Day Track
S020 2001-06-11 Normal 180 Day Track
S019 2001-02-23 Normal 180 Day Track
S018 2001-01-12 Real-time Process
S017 2000-09-27 Normal 180 Day Track
S016 2000-10-06 Real-time Process
S015 2000-08-07 Real-time Process
S014 2000-05-30 30-day Notice
S013 2000-05-08 Normal 180 Day Track
S012 2000-05-15 Real-time Process
S011 2000-04-13 Real-time Process
S010
S009 1999-05-14 Real-time Process
S008 1999-03-01 Normal 180 Day Track
S007 1999-01-20 Normal 180 Day Track
S006 1998-12-10 Normal 180 Day Track
S005 1998-10-26 Real-time Process
S004 1998-08-31 Real-time Process
S003 1998-06-09 Real-time Process
S002 1998-07-06 Real-time Process
S001 1997-03-31 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04035479109790 P950037 072
04035479062279 P950037 089
04035479161750 P950037 166
04035479166106 P950037 166
04035479166403 P950037 166
04035479167493 P950037 166

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.