P950022S112

None

FDA Premarket Approval P950022 S112

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

DeviceP950022S112
Classification NameNone
Applicant
PMAP950022
SupplementS112

Supplemental Filings

Supplement NumberDateSupplement Type
P950022Original Filing
S131 2020-03-12 Normal 180 Day Track No User Fee
S130 2020-02-27 30-day Notice
S129 2020-01-27 30-day Notice
S128 2019-09-27 30-day Notice
S127
S126 2018-11-30 30-day Notice
S125 2018-11-23 30-day Notice
S124 2018-11-20 30-day Notice
S123 2018-10-02 30-day Notice
S122 2018-10-01 30-day Notice
S121 2018-09-28 30-day Notice
S120 2018-07-02 30-day Notice
S119 2018-04-02 Real-time Process
S118 2018-03-05 30-day Notice
S117 2018-02-27 30-day Notice
S116 2018-02-26 30-day Notice
S115 2018-01-31 30-day Notice
S114 2018-01-26 30-day Notice
S113 2017-12-21 30-day Notice
S112
S111 2017-09-22 30-day Notice
S110 2017-07-28 Real-time Process
S109 2017-07-03 Normal 180 Day Track
S108 2017-06-27 30-day Notice
S107 2017-06-16 Normal 180 Day Track
S106 2017-05-24 30-day Notice
S105 2017-04-03 Normal 180 Day Track
S104 2017-02-28 30-day Notice
S103 2017-02-24 30-day Notice
S102 2017-02-17 135 Review Track For 30-day Notice
S101 2017-02-10 30-day Notice
S100 2017-01-26 30-day Notice
S099 2017-01-25 30-day Notice
S098 2016-12-13 30-day Notice
S097 2016-11-08 30-day Notice
S096 2016-10-12 30-day Notice
S095 2016-09-27 135 Review Track For 30-day Notice
S094
S093 2016-06-22 30-day Notice
S092 2016-04-12 30-day Notice
S091 2016-01-19 30-day Notice
S090 2015-12-15 30-day Notice
S089 2015-10-26 135 Review Track For 30-day Notice
S088 2015-08-10 30-day Notice
S087 2014-09-29 30-day Notice
S086 2013-05-02 30-day Notice
S085 2012-10-24 Normal 180 Day Track
S084 2012-09-13 30-day Notice
S083 2012-09-05 Real-time Process
S082
S081 2012-01-09 135 Review Track For 30-day Notice
S080 2011-11-30 135 Review Track For 30-day Notice
S079 2011-11-07 Normal 180 Day Track
S078 2011-09-20 Real-time Process
S077 2011-06-20 Real-time Process
S076 2011-01-27 30-day Notice
S075 2010-10-21 Real-time Process
S074 2010-08-16 Normal 180 Day Track No User Fee
S073 2010-07-13 Normal 180 Day Track No User Fee
S072 2010-06-30 135 Review Track For 30-day Notice
S071 2010-06-15 30-day Notice
S070 2010-04-30 Real-time Process
S069 2010-04-22 Normal 180 Day Track
S068 2009-12-24 30-day Notice
S067 2009-11-25 Normal 180 Day Track No User Fee
S066
S065
S064 2009-08-28 30-day Notice
S063 2009-08-04 Real-time Process
S062 2009-06-10 30-day Notice
S061 2009-06-03 30-day Notice
S060 2009-05-14 Real-time Process
S059
S058 2009-02-06 Normal 180 Day Track No User Fee
S057 2009-01-30 30-day Notice
S056 2009-01-21 Normal 180 Day Track No User Fee
S055 2009-01-14 135 Review Track For 30-day Notice
S054 2008-09-29 135 Review Track For 30-day Notice
S053 2008-05-21 30-day Notice
S052 2008-05-07 Real-time Process
S051 2008-02-01 Normal 180 Day Track No User Fee
S050 2008-01-15 30-day Notice
S049 2007-12-03 Normal 180 Day Track No User Fee
S048 2007-11-19 30-day Notice
S047 2007-11-19 30-day Notice
S046 2007-11-05 135 Review Track For 30-day Notice
S045 2007-10-19 Normal 180 Day Track No User Fee
S044
S043 2007-09-20 30-day Notice
S042 2007-09-05 Normal 180 Day Track
S041 2007-08-22 Real-time Process
S040 2007-07-06 Real-time Process
S039 2007-05-10 30-day Notice
S038 2007-05-09 30-day Notice
S037 2007-02-26 30-day Notice
S036 2007-02-26 30-day Notice
S035 2007-02-21 30-day Notice
S034 2006-12-19 Real-time Process
S033 2006-11-15 135 Review Track For 30-day Notice
S032 2006-11-02 Real-time Process
S031 2006-10-16 30-day Notice
S030 2006-06-05 Real-time Process
S029
S028 2006-02-13 Real-time Process
S027 2006-02-10 Real-time Process
S026 2005-08-15 30-day Notice
S025 2005-05-31 Normal 180 Day Track
S024 2005-04-21 Real-time Process
S023 2005-04-05 30-day Notice
S022 2005-04-05 30-day Notice
S021 2005-04-05 30-day Notice
S020 2005-04-05 30-day Notice
S019 2005-03-25 Real-time Process
S018 2004-03-11 Real-time Process
S017 2003-06-09 Real-time Process
S016 2002-12-31 Real-time Process
S015 2002-12-04 Real-time Process
S014 2002-01-31 Real-time Process
S013 2001-08-10 Normal 180 Day Track
S012 2000-12-19 30-day Notice
S011 2000-08-17 Normal 180 Day Track
S010 2000-08-11 Normal 180 Day Track
S009 2000-06-08 Real-time Process
S008 2000-03-20 30-day Notice
S007 1999-12-14 Real-time Process
S006 1999-05-24 Normal 180 Day Track
S005 1999-02-08 Normal 180 Day Track
S004 1998-11-23 Real-time Process
S003 1998-08-20 Normal 180 Day Track
S002 1997-04-14 Normal 180 Day Track
S001 1996-10-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734500333 P950022 014
05414734503174 P950022 042
05414734502818 P950022 042
05414734503204 P950022 042
05414734503211 P950022 042
05414734503167 P950022 042
05414734503228 P950022 042
05414734503730 P950022 042
05414734503037 P950022 042
05414734505123 P950022 049
H75871306009 P950022 049
05414734502146 P950022 049
05414734505109 P950022 049
05414734505116 P950022 049
05414734502443 P950022 049
05414734502085 P950022 049
05414734502092 P950022 049
05414734502108 P950022 049
05414734502115 P950022 049
05414734502122 P950022 049
05414734505130 P950022 049
05414734502153 P950022 049
05414734502436 P950022 049
05414734502160 P950022 049
05414734502139 P950022 049
05414734503297 P950022 060
05414734503266 P950022 060
05414734503242 P950022 060
05414734503280 P950022 060
05414734503259 P950022 060
05414734503273 P950022 060
05414734504973 P950022 069
05414734504676 P950022 077
05414734507165 P950022 085
05414734507325 P950022 085
05414734507332 P950022 085
05414734507349 P950022 085
05414734507356 P950022 085
05414734507363 P950022 085
05414734507370 P950022 085
05414734507387 P950022 085
05414734507394 P950022 085
05414734507431 P950022 085
05414734507448 P950022 085
05414734507455 P950022 085
05414734507462 P950022 085
05414734507479 P950022 085
05414734507318 P950022 085
05414734507301 P950022 085
05414734507172 P950022 085
05414734507189 P950022 085
05414734507196 P950022 085
05414734507202 P950022 085
05414734507219 P950022 085
05414734507226 P950022 085
05414734507233 P950022 085
05414734507240 P950022 085
05414734507257 P950022 085
05414734507264 P950022 085
05414734507271 P950022 085
05414734507288 P950022 085
05414734507295 P950022 085
05414734507486 P950022 085

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