P970051S185

None

FDA Premarket Approval P970051 S185

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

DeviceP970051S185
Classification NameNone
Applicant
PMAP970051
SupplementS185

Supplemental Filings

Supplement NumberDateSupplement Type
P970051Original Filing
S192 2019-09-09 30-day Notice
S191
S190
S189 2019-07-31 30-day Notice
S188
S187
S186 2019-06-06 30-day Notice
S185
S184 2019-01-30 30-day Notice
S183
S182 2018-11-01 Normal 180 Day Track
S181 2018-08-13 30-day Notice
S180 2018-06-11 Special (immediate Track)
S179 2018-04-27 Special (immediate Track)
S178 2018-04-13 30-day Notice
S177 2018-02-15 30-day Notice
S176 2018-02-02 30-day Notice
S175 2018-01-02 30-day Notice
S174 2018-01-02 30-day Notice
S173 2017-11-13 Normal 180 Day Track
S172
S171 2017-09-28 30-day Notice
S170 2017-08-25 135 Review Track For 30-day Notice
S169 2017-08-07 30-day Notice
S168 2017-07-26 30-day Notice
S167 2017-07-17 30-day Notice
S166 2017-06-21 Real-time Process
S165 2017-06-07 30-day Notice
S164 2017-05-23 Normal 180 Day Track
S163 2017-05-16 30-day Notice
S162 2017-04-24 30-day Notice
S161 2017-04-18 Real-time Process
S160 2017-04-10 30-day Notice
S159 2017-03-23 30-day Notice
S158 2017-02-27 30-day Notice
S157 2017-02-09 Special (immediate Track)
S156 2017-02-07 30-day Notice
S155 2016-12-21 30-day Notice
S154 2016-11-23 30-day Notice
S153 2016-11-23 30-day Notice
S152
S151 2016-10-12 Normal 180 Day Track
S150 2016-09-22 30-day Notice
S149 2016-07-25 30-day Notice
S148 2016-06-23 30-day Notice
S147 2016-06-15 135 Review Track For 30-day Notice
S146 2016-05-27 30-day Notice
S145 2016-02-24 30-day Notice
S144 2016-02-24 Normal 180 Day Track
S143 2016-02-08 Normal 180 Day Track
S142 2016-01-06 30-day Notice
S141 2016-01-05 30-day Notice
S140 2015-12-23 Normal 180 Day Track
S139 2015-12-17 30-day Notice
S138 2015-12-04 30-day Notice
S137 2015-11-23 Normal 180 Day Track
S136 2015-10-23 30-day Notice
S135 2015-10-13 30-day Notice
S134 2015-09-14 30-day Notice
S133 2015-07-31 Normal 180 Day Track
S132 2015-07-23 Normal 180 Day Track No User Fee
S131 2015-05-18 135 Review Track For 30-day Notice
S130 2015-05-07 135 Review Track For 30-day Notice
S129 2015-03-23 Real-time Process
S128 2015-02-13 30-day Notice
S127 2014-12-24 30-day Notice
S126 2014-11-14 Normal 180 Day Track
S125 2014-11-12 30-day Notice
S124 2014-11-12 30-day Notice
S123 2014-10-02 Normal 180 Day Track
S122 2014-07-23 30-day Notice
S121 2014-06-09 Real-time Process
S120 2014-05-16 30-day Notice
S119 2014-04-17 30-day Notice
S118 2014-03-28 30-day Notice
S117
S116 2014-01-27 Normal 180 Day Track
S115 2014-01-22 30-day Notice
S114 2014-01-15 Real-time Process
S113 2013-10-22 135 Review Track For 30-day Notice
S112 2013-09-26 Real-time Process
S111 2013-07-29 30-day Notice
S110 2013-06-28 Normal 180 Day Track
S109 2013-04-10 30-day Notice
S108 2013-04-04 135 Review Track For 30-day Notice
S107 2013-03-27 135 Review Track For 30-day Notice
S106 2013-02-25 30-day Notice
S105 2013-02-07 135 Review Track For 30-day Notice
S104 2013-01-16 Normal 180 Day Track
S103 2012-12-24 Real-time Process
S102
S101 2012-11-15 135 Review Track For 30-day Notice
S100 2012-11-15 135 Review Track For 30-day Notice
S099
S098 2012-10-23 30-day Notice
S097 2012-09-11 Real-time Process
S096 2012-08-27 Normal 180 Day Track
S095 2012-08-06 30-day Notice
S094 2012-08-02 Normal 180 Day Track
S093 2012-07-31 Real-time Process
S092 2012-07-27 30-day Notice
S091 2012-07-13 Normal 180 Day Track
S090
S089 2011-12-30 Real-time Process
S088 2011-10-26 Real-time Process
S087 2011-09-22 Real-time Process
S086 2011-08-29 135 Review Track For 30-day Notice
S085 2011-08-05 Real-time Process
S084
S083
S082 2011-06-29 135 Review Track For 30-day Notice
S081
S080 2011-06-27 30-day Notice
S079
S078 2011-06-24 30-day Notice
S077 2011-05-19 30-day Notice
S076 2011-05-19 30-day Notice
S075 2011-05-19 135 Review Track For 30-day Notice
S074 2011-05-19 135 Review Track For 30-day Notice
S073 2011-05-19 135 Review Track For 30-day Notice
S072
S071 2011-05-16 30-day Notice
S070 2011-05-16 135 Review Track For 30-day Notice
S069 2011-04-06 Real-time Process
S068 2011-03-10 Special (immediate Track)
S067 2011-02-03 30-day Notice
S066
S065 2010-11-19 30-day Notice
S064 2010-10-01 Normal 180 Day Track
S063 2010-09-27 Real-time Process
S062 2009-12-23 Real-time Process
S061
S060 2009-12-09 135 Review Track For 30-day Notice
S059 2009-11-09 135 Review Track For 30-day Notice
S058 2009-11-02 30-day Notice
S057 2009-10-26 135 Review Track For 30-day Notice
S056
S055 2009-10-13 Special (immediate Track)
S054 2009-10-05 135 Review Track For 30-day Notice
S053 2009-09-25 Normal 180 Day Track
S052 2009-07-22 135 Review Track For 30-day Notice
S051 2009-06-11 30-day Notice
S050 2009-05-20 Real-time Process
S049 2008-12-19 Normal 180 Day Track
S048 2008-11-25 Normal 180 Day Track
S047 2008-08-08 30-day Notice
S046 2008-07-25 30-day Notice
S045 2007-10-09 Real-time Process
S044 2007-08-24 30-day Notice
S043 2007-08-24 30-day Notice
S042 2007-08-24 30-day Notice
S041 2007-08-24 30-day Notice
S040
S039 2006-09-05 30-day Notice
S038 2006-04-21 Real-time Process
S037 2006-04-13 Real-time Process
S036 2006-01-24 30-day Notice
S035 2005-12-20 Real-time Process
S034 2005-09-23 Real-time Process
S033
S032
S031 2005-03-15 Real-time Process
S030 2005-03-09 30-day Notice
S029 2004-09-17 Normal 180 Day Track
S028 2004-07-01 Normal 180 Day Track
S027 2003-10-06 Real-time Process
S026 2003-09-04 Real-time Process
S025 2003-08-13 Normal 180 Day Track No User Fee
S024 2002-12-06 Normal 180 Day Track
S023 2002-10-31 Normal 180 Day Track
S022 2002-08-28 Special (immediate Track)
S021 2002-07-16 Normal 180 Day Track
S020 2002-06-13 Real-time Process
S019 2001-10-23 Normal 180 Day Track
S018 2001-07-23 Normal 180 Day Track
S017 2001-06-22 Normal 180 Day Track
S016 2001-04-19 Normal 180 Day Track
S015 2001-03-19 Normal 180 Day Track
S014 2001-01-16 Real-time Process
S013 2000-12-29 Normal 180 Day Track
S012 2000-11-29 Normal 180 Day Track
S011 2000-07-21 Normal 180 Day Track
S010 2000-02-23 Normal 180 Day Track
S009 1999-12-17 Real-time Process
S008 1999-09-20 Normal 180 Day Track
S007 1999-08-13 Real-time Process
S006 1999-04-15 30-day Notice
S005 1999-03-26 Real-time Process
S004 1999-01-08 Normal 180 Day Track
S003 1998-08-17 Normal 180 Day Track
S002 1998-07-20 Real-time Process
S001 1998-07-16 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
09321502044103 P970051 182
09321502044066 P970051 182
09321502044936 P970051 182
09321502046541 P970051 182
09321502043984 P970051 182
09321502043991 P970051 182
09321502044004 P970051 182
09321502044011 P970051 182
09321502044059 P970051 182
09321502044073 P970051 182
09321502044080 P970051 182
09321502036580 P970051 183
09321502036818 P970051 183
09321502039413 P970051 183
09321502039420 P970051 183
09321502036573 P970051 183

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