P980049S137

None

FDA Premarket Approval P980049 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

DeviceP980049S137
Classification NameNone
Applicant
PMAP980049
SupplementS137

Supplemental Filings

Supplement NumberDateSupplement Type
P980049Original Filing
S140 2020-09-24 30-day Notice
S139
S138 2020-07-13 30-day Notice
S137
S136 2020-02-10 30-day Notice
S135
S134 2019-02-05 30-day Notice
S133 2018-12-20 Real-time Process
S132 2018-11-13 30-day Notice
S131 2018-04-19 30-day Notice
S130 2018-03-29 30-day Notice
S129 2018-02-26 30-day Notice
S128 2018-01-03 Real-time Process
S127 2018-01-03 30-day Notice
S126 2017-07-07 30-day Notice
S125 2017-05-22 Real-time Process
S124 2017-02-21 30-day Notice
S123 2016-12-19 Normal 180 Day Track
S122 2016-08-23 30-day Notice
S121 2016-08-23 30-day Notice
S120 2016-08-23 30-day Notice
S119 2016-08-09 Real-time Process
S118 2016-07-26 Real-time Process
S117 2016-07-21 Real-time Process
S116 2016-07-14 30-day Notice
S115 2016-07-13 30-day Notice
S114 2015-11-17 135 Review Track For 30-day Notice
S113 2015-10-20 Normal 180 Day Track
S112 2015-07-07 30-day Notice
S111 2015-07-02 30-day Notice
S110 2015-07-01 30-day Notice
S109 2015-03-30 Normal 180 Day Track
S108 2015-02-24 30-day Notice
S107 2015-02-19 30-day Notice
S106 2015-02-18 30-day Notice
S105 2015-02-11 Normal 180 Day Track
S104 2014-11-21 30-day Notice
S103 2014-10-01 Normal 180 Day Track No User Fee
S102 2014-09-15 Real-time Process
S101 2014-08-05 30-day Notice
S100 2014-06-20 30-day Notice
S099 2014-05-15 Normal 180 Day Track
S098 2014-04-24 Real-time Process
S097 2014-04-23 Real-time Process
S096 2014-04-10 30-day Notice
S095 2014-03-24 30-day Notice
S094 2014-03-18 Real-time Process
S093 2014-02-12 Real-time Process
S092 2014-01-29 30-day Notice
S091 2014-01-29 30-day Notice
S090 2014-01-10 Real-time Process
S089 2013-10-31 30-day Notice
S088 2013-10-17 30-day Notice
S087 2013-09-11 30-day Notice
S086 2013-09-11 30-day Notice
S085 2013-08-21 Normal 180 Day Track
S084
S083 2013-07-15 30-day Notice
S082 2013-04-10 30-day Notice
S081 2013-02-25 30-day Notice
S080 2013-02-15 Real-time Process
S079 2013-02-11 30-day Notice
S078 2012-12-21 30-day Notice
S077 2012-07-31 30-day Notice
S076 2012-07-06 30-day Notice
S075 2012-07-05 30-day Notice
S074 2012-05-16 30-day Notice
S073 2012-05-16 30-day Notice
S072 2012-03-23 30-day Notice
S071 2012-03-13 Normal 180 Day Track
S070 2012-01-27 30-day Notice
S069 2012-01-05 30-day Notice
S068 2011-12-12 30-day Notice
S067 2011-11-10 30-day Notice
S066 2011-10-31 30-day Notice
S065 2011-09-01 Normal 180 Day Track
S064 2011-06-06 30-day Notice
S063 2011-02-28 30-day Notice
S062 2010-12-16 Real-time Process
S061 2010-11-29 Normal 180 Day Track No User Fee
S060 2010-08-12 Real-time Process
S059 2010-06-28 Normal 180 Day Track
S058 2010-06-04 30-day Notice
S057 2010-05-17 Real-time Process
S056 2010-04-26 30-day Notice
S055 2010-03-23 30-day Notice
S054 2010-02-12 30-day Notice
S053 2010-02-04 135 Review Track For 30-day Notice
S052
S051 2009-11-16 30-day Notice
S050 2009-09-24 Normal 180 Day Track
S049 2009-06-16 Special (immediate Track)
S048 2009-04-09 30-day Notice
S047 2009-03-31 30-day Notice
S046 2009-03-04 30-day Notice
S045 2009-01-28 30-day Notice
S044 2008-11-12 Real-time Process
S043 2008-11-10 30-day Notice
S042 2008-09-15 30-day Notice
S041 2008-08-21 Real-time Process
S040 2008-08-13 Normal 180 Day Track
S039 2008-08-06 Real-time Process
S038 2008-06-23 Special (immediate Track)
S037 2008-06-10 Real-time Process
S036 2008-03-13 135 Review Track For 30-day Notice
S035 2008-03-05 Real-time Process
S034
S033 2008-02-15 30-day Notice
S032 2008-02-15 30-day Notice
S031 2008-02-15 30-day Notice
S030 2008-02-14 30-day Notice
S029 2008-02-11 135 Review Track For 30-day Notice
S028 2007-08-29 Real-time Process
S027 2007-05-25 Normal 180 Day Track No User Fee
S026 2007-04-19 30-day Notice
S025 2007-01-24 Normal 180 Day Track
S024 2006-10-16 Normal 180 Day Track
S023 2006-07-11 Real-time Process
S022 2006-01-17 Real-time Process
S021 2005-05-16 Normal 180 Day Track
S020 2005-04-29 Normal 180 Day Track
S019 2005-04-13 30-day Notice
S018 2005-01-31 30-day Notice
S017 2004-09-15 Real-time Process
S016 2004-08-18 135 Review Track For 30-day Notice
S015 2004-03-03 Real-time Process
S014 2004-02-23 Real-time Process
S013 2004-02-20 Real-time Process
S012 2004-02-17 Special (immediate Track)
S011 2003-09-23 Real-time Process
S010 2003-09-11 Real-time Process
S009 2003-05-22 Real-time Process
S008 2002-04-15 Normal 180 Day Track
S007 2001-11-30 Real-time Process
S006 2001-11-28 Real-time Process
S005 2001-05-17 Real-time Process
S004 2001-01-16 Real-time Process
S003 2000-11-21 Real-time Process
S002 2000-07-06 Normal 180 Day Track
S001 1999-10-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
08031527012261 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012261 P980049 065
08031527012254 P980049 065
08031527012254 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012261 P980049 065
08031527012261 P980049 065
08031527012254 P980049 065
08031527012254 P980049 065
08031527012254 P980049 065
08031527012261 P980049 065
08031527012827 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527012827 P980049 099
08031527012834 P980049 099
08031527015477 P980049 113
08031527015521 P980049 113
08031527015521 P980049 113
08031527015460 P980049 113
08031527015460 P980049 113
08031527015514 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015477 P980049 113
08031527015514 P980049 113
08031527015521 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015460 P980049 113
08031527015477 P980049 113
08031527015514 P980049 113
08031527015514 P980049 113
08031527015521 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015477 P980049 113
08031527016375 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015514 P980049 113
08031527015460 P980049 113
08031527015477 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015477 P980049 113
08031527015460 P980049 113
08031527015521 P980049 113
08031527015514 P980049 113
08031527015460 P980049 113
08031527016788 P980049 118
08031527017174 P980049 125

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