P060039S017

None

FDA Premarket Approval P060039 S017

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

DeviceP060039S017
Classification NameNone
Applicant
PMAP060039
SupplementS017

Supplemental Filings

Supplement NumberDateSupplement Type
P060039Original Filing
S112 2022-11-16 30-day Notice
S111 2022-05-20 30-day Notice
S110 2022-04-14 30-day Notice
S109 2021-11-18 30-day Notice
S108 2021-08-09 30-day Notice
S107 2021-06-15 30-day Notice
S106 2021-02-05 30-day Notice
S105 2020-12-01 30-day Notice
S104 2020-11-24 30-day Notice
S103 2020-11-13 30-day Notice
S102 2020-10-23 30-day Notice
S101 2020-07-09 30-day Notice
S100 2020-06-26 30-day Notice
S099 2020-02-20 30-day Notice
S098 2019-11-18 30-day Notice
S097
S096 2019-09-16 30-day Notice
S095 2019-06-20 30-day Notice
S094 2019-06-10 30-day Notice
S093 2019-02-28 30-day Notice
S092 2018-10-23 30-day Notice
S091 2018-10-18 30-day Notice
S090 2018-09-26 30-day Notice
S089 2018-06-20 30-day Notice
S088 2018-06-01 30-day Notice
S087 2018-05-15 30-day Notice
S086 2018-04-09 30-day Notice
S085 2018-03-28 30-day Notice
S084 2018-02-22 30-day Notice
S083 2018-01-26 Normal 180 Day Track No User Fee
S082 2017-11-20 30-day Notice
S081 2017-08-07 30-day Notice
S080 2017-06-27 30-day Notice
S079 2017-06-23 30-day Notice
S078 2017-06-07 30-day Notice
S077 2017-01-17 30-day Notice
S076 2016-11-28 30-day Notice
S075 2016-11-14 30-day Notice
S074 2016-10-05 30-day Notice
S073 2016-09-12 30-day Notice
S072 2016-09-02 30-day Notice
S071 2016-06-24 30-day Notice
S070 2016-06-13 30-day Notice
S069 2015-12-28 30-day Notice
S068 2015-12-22 30-day Notice
S067 2015-04-17 30-day Notice
S066 2015-02-09 30-day Notice
S065 2014-12-03 135 Review Track For 30-day Notice
S064 2014-09-29 30-day Notice
S063 2014-08-27 30-day Notice
S062 2014-08-22 Normal 180 Day Track No User Fee
S061 2014-08-08 30-day Notice
S060 2014-07-24 30-day Notice
S059 2014-06-26 Normal 180 Day Track
S058 2014-03-18 30-day Notice
S057 2014-02-27 30-day Notice
S056 2014-02-07 Normal 180 Day Track No User Fee
S055 2013-12-24 30-day Notice
S054 2013-12-19 30-day Notice
S053 2013-10-30 30-day Notice
S052 2013-10-24 30-day Notice
S051 2013-09-30 30-day Notice
S050 2013-09-17 30-day Notice
S049 2013-09-13 Normal 180 Day Track No User Fee
S048
S047 2013-05-17 Real-time Process
S046 2013-04-30 30-day Notice
S045
S044 2013-04-10 Normal 180 Day Track No User Fee
S043 2013-03-22 30-day Notice
S042 2013-03-20 30-day Notice
S041 2012-12-10 30-day Notice
S040 2012-11-29 30-day Notice
S039 2012-11-21 30-day Notice
S038 2012-09-28 30-day Notice
S037 2012-09-21 30-day Notice
S036 2012-09-04 30-day Notice
S035 2012-08-03 30-day Notice
S034 2012-02-29 30-day Notice
S033 2012-02-22 Normal 180 Day Track No User Fee
S032 2011-11-25 30-day Notice
S031 2011-11-21 Normal 180 Day Track
S030 2011-07-18 30-day Notice
S029 2011-07-08 30-day Notice
S028 2011-06-28 30-day Notice
S027 2011-06-08 30-day Notice
S026 2011-06-08 135 Review Track For 30-day Notice
S025 2011-04-26 30-day Notice
S024 2011-03-22 135 Review Track For 30-day Notice
S023 2011-03-18 135 Review Track For 30-day Notice
S022 2011-02-28 30-day Notice
S021 2011-01-26 Normal 180 Day Track
S020 2010-11-12 30-day Notice
S019 2010-10-26 30-day Notice
S018 2010-10-14 30-day Notice
S017
S016 2010-08-23 Normal 180 Day Track No User Fee
S015 2010-07-15 30-day Notice
S014 2010-07-15 30-day Notice
S013 2010-06-28 135 Review Track For 30-day Notice
S012 2010-06-09 30-day Notice
S011 2010-03-29 30-day Notice
S010 2010-02-19 Normal 180 Day Track No User Fee
S009 2010-01-19 30-day Notice
S008 2009-10-26 Normal 180 Day Track No User Fee
S007 2009-10-08 Real-time Process
S006 2009-08-27 Normal 180 Day Track
S005 2008-12-11 30-day Notice
S004 2008-11-03 30-day Notice
S003 2008-07-21 Normal 180 Day Track
S002 2008-07-14 Normal 180 Day Track No User Fee
S001 2008-07-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00885074511986 P060039 000
00885074511962 P060039 000
00885074511955 P060039 000
00643169590656 P060039 061
00643169590649 P060039 061
00643169590632 P060039 061

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