P080006S137

None

FDA Premarket Approval P080006 S137

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

DeviceP080006S137
Classification NameNone
Applicant
PMAP080006
SupplementS137

Supplemental Filings

Supplement NumberDateSupplement Type
P080006Original Filing
S146 2020-02-20 30-day Notice
S145
S144 2019-12-05 30-day Notice
S143 2019-11-18 30-day Notice
S142
S141 2019-10-17 30-day Notice
S140 2019-09-16 30-day Notice
S139 2019-07-12 Normal 180 Day Track No User Fee
S138 2019-07-01 30-day Notice
S137
S136 2019-06-20 30-day Notice
S135 2019-06-10 30-day Notice
S134 2019-05-31 30-day Notice
S133 2019-05-02 Normal 180 Day Track No User Fee
S132 2019-04-15 30-day Notice
S131 2019-02-28 30-day Notice
S130 2019-02-04 30-day Notice
S129 2018-10-26 Normal 180 Day Track
S128 2018-10-23 30-day Notice
S127 2018-10-18 30-day Notice
S126 2018-09-26 30-day Notice
S125 2018-06-20 30-day Notice
S124 2018-06-05 30-day Notice
S123 2018-06-01 30-day Notice
S122 2018-05-15 30-day Notice
S121 2018-04-13 Normal 180 Day Track
S120 2018-04-09 30-day Notice
S119 2018-03-28 30-day Notice
S118 2018-02-22 30-day Notice
S117 2017-12-21 30-day Notice
S116 2017-11-20 30-day Notice
S115 2017-08-31 30-day Notice
S114 2017-08-31 Normal 180 Day Track No User Fee
S113 2017-08-07 30-day Notice
S112 2017-06-28 30-day Notice
S111 2017-06-27 30-day Notice
S110 2017-06-23 30-day Notice
S109 2017-06-07 30-day Notice
S108 2017-01-25 30-day Notice
S107 2017-01-25 Real-time Process
S106 2017-01-17 30-day Notice
S105 2016-12-06 Normal 180 Day Track
S104 2016-11-28 30-day Notice
S103 2016-11-14 30-day Notice
S102 2016-11-10 30-day Notice
S101 2016-11-02 Normal 180 Day Track
S100 2016-10-05 30-day Notice
S099 2016-09-12 30-day Notice
S098 2016-09-02 30-day Notice
S097 2016-08-25 30-day Notice
S096 2016-06-24 30-day Notice
S095 2016-06-03 Real-time Process
S094 2016-06-02 30-day Notice
S093 2016-05-03 Normal 180 Day Track
S092 2016-05-03 30-day Notice
S091 2016-03-21 30-day Notice
S090 2016-03-11 Normal 180 Day Track
S089 2016-03-01 Normal 180 Day Track
S088 2016-01-19 30-day Notice
S087 2015-12-28 30-day Notice
S086 2015-12-22 30-day Notice
S085 2015-09-24 Normal 180 Day Track
S084 2015-09-10 30-day Notice
S083
S082 2015-06-02 30-day Notice
S081 2015-04-30 Normal 180 Day Track No User Fee
S080 2015-04-20 30-day Notice
S079 2015-04-17 30-day Notice
S078 2015-04-03 30-day Notice
S077 2015-03-12 30-day Notice
S076 2015-02-09 30-day Notice
S075 2014-10-15 30-day Notice
S074 2014-09-17 30-day Notice
S073 2014-09-09 Normal 180 Day Track
S072 2014-08-27 30-day Notice
S071 2014-08-22 30-day Notice
S070 2014-08-08 30-day Notice
S069 2014-07-24 30-day Notice
S068 2014-04-01 Normal 180 Day Track
S067 2014-02-27 30-day Notice
S066 2014-01-22 30-day Notice
S065 2013-12-24 30-day Notice
S064 2013-12-19 30-day Notice
S063 2013-11-27 Normal 180 Day Track
S062 2013-11-26 30-day Notice
S061 2013-11-22 30-day Notice
S060 2013-10-30 30-day Notice
S059 2013-10-24 30-day Notice
S058 2013-09-30 30-day Notice
S057 2013-08-13 Normal 180 Day Track No User Fee
S056 2013-07-25 30-day Notice
S055 2013-05-21 30-day Notice
S054 2013-05-17 Real-time Process
S053 2013-04-30 30-day Notice
S052 2013-04-10 Normal 180 Day Track No User Fee
S051 2013-03-22 30-day Notice
S050 2013-03-20 30-day Notice
S049 2012-12-10 30-day Notice
S048 2012-11-29 30-day Notice
S047 2012-11-21 30-day Notice
S046 2012-10-22 30-day Notice
S045 2012-09-28 30-day Notice
S044 2012-09-04 30-day Notice
S043 2012-08-21 30-day Notice
S042 2012-08-03 30-day Notice
S041 2012-06-11 30-day Notice
S040 2012-02-29 30-day Notice
S039 2012-02-23 30-day Notice
S038 2012-02-13 30-day Notice
S037 2011-11-25 30-day Notice
S036 2011-11-21 Normal 180 Day Track
S035 2011-10-24 135 Review Track For 30-day Notice
S034 2011-07-16 30-day Notice
S033 2011-07-08 30-day Notice
S032 2011-06-28 30-day Notice
S031 2011-06-13 30-day Notice
S030 2011-06-08 30-day Notice
S029 2011-06-08 135 Review Track For 30-day Notice
S028 2011-05-13 30-day Notice
S027 2011-05-09 30-day Notice
S026 2011-05-03 30-day Notice
S025 2011-04-26 30-day Notice
S024 2011-04-25 30-day Notice
S023 2011-04-22 30-day Notice
S022 2011-04-07 30-day Notice
S021 2011-03-22 135 Review Track For 30-day Notice
S020 2011-02-28 30-day Notice
S019 2010-12-21 30-day Notice
S018 2010-11-12 30-day Notice
S017 2010-10-26 30-day Notice
S016 2010-10-14 30-day Notice
S015
S014 2010-08-23 Normal 180 Day Track No User Fee
S013 2010-07-15 30-day Notice
S012 2010-07-15 30-day Notice
S011 2010-07-06 30-day Notice
S010 2010-06-28 135 Review Track For 30-day Notice
S009 2010-06-09 30-day Notice
S008 2010-05-17 30-day Notice
S007 2010-03-29 30-day Notice
S006 2010-01-29 Normal 180 Day Track No User Fee
S005 2009-10-30 Normal 180 Day Track
S004 2009-10-19 Normal 180 Day Track
S003 2009-10-08 Real-time Process
S002 2009-06-10 Normal 180 Day Track
S001 2009-04-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00613994469724 P080006 000
00613994469731 P080006 000
00613994469731 P080006 000
00613994469724 P080006 000
00613994719171 P080006 002
00613994719133 P080006 002
00613994719171 P080006 002
00613994719133 P080006 002
00613994719096 P080006 004
00613994719096 P080006 004
00613994719058 P080006 004
00613994719058 P080006 004
00643169002685 P080006 068
00643169002685 P080006 068
00643169002715 P080006 068
00643169002715 P080006 068
00643169169081 P080006 073
00643169169081 P080006 073
00643169169036 P080006 073
00643169169036 P080006 073
00643169002517 P080006 073
00643169002487 P080006 073
00643169002517 P080006 073
00643169002487 P080006 073
00643169601864 P080006 085
00643169601840 P080006 085
00643169601833 P080006 085
00643169601826 P080006 085
00643169601819 P080006 085
00643169601802 P080006 085
00643169601796 P080006 085
00643169601789 P080006 085
00643169601772 P080006 085
00643169601765 P080006 085
00643169601871 P080006 085
00643169601826 P080006 085
00643169601864 P080006 085
00643169601857 P080006 085
00643169601840 P080006 085
00643169601833 P080006 085
00643169601819 P080006 085
00643169601802 P080006 085
00643169601796 P080006 085
00643169601789 P080006 085
00643169601772 P080006 085
00643169601871 P080006 085
00643169601857 P080006 085
00643169601765 P080006 085
00643169860032 P080006 095
00643169860025 P080006 095
00643169860131 P080006 095
00643169860223 P080006 095
00643169860230 P080006 095
00643169860124 P080006 095
00643169860025 P080006 095
00643169860230 P080006 095
00643169860131 P080006 095
00643169860223 P080006 095
00643169860124 P080006 095
00643169860032 P080006 095
00643169860421 P080006 129
00643169860414 P080006 129

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