P030009S017

None

FDA Premarket Approval P030009 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

DeviceP030009S017
Classification NameNone
Applicant
PMAP030009
SupplementS017

Supplemental Filings

Supplement NumberDateSupplement Type
P030009Original Filing
S107 2022-03-23 30-day Notice
S106 2021-10-28 30-day Notice
S105
S104
S103 2021-04-23 Special (immediate Track)
S102 2021-04-12 30-day Notice
S101
S100 2021-03-04 30-day Notice
S099 2021-01-25 30-day Notice
S098 2020-10-26 30-day Notice
S097 2020-07-10 Normal 180 Day Track No User Fee
S096 2020-05-04 30-day Notice
S095 2018-09-24 30-day Notice
S094 2018-09-24 30-day Notice
S093 2017-11-20 30-day Notice
S092 2017-07-03 Real-time Process
S091 2017-01-30 30-day Notice
S090 2016-09-02 30-day Notice
S089 2016-08-17 135 Review Track For 30-day Notice
S088 2016-07-13 30-day Notice
S087 2016-05-16 30-day Notice
S086 2016-04-22 135 Review Track For 30-day Notice
S085 2016-03-14 30-day Notice
S084
S083 2016-01-29 30-day Notice
S082 2015-08-17 30-day Notice
S081 2015-05-14 30-day Notice
S080 2015-03-20 135 Review Track For 30-day Notice
S079 2014-07-02 30-day Notice
S078 2014-04-25 30-day Notice
S077 2014-04-03 30-day Notice
S076 2014-03-18 30-day Notice
S075 2014-02-18 30-day Notice
S074 2014-02-03 Special (immediate Track)
S073 2013-12-16 30-day Notice
S072 2013-11-22 30-day Notice
S071 2013-11-18 30-day Notice
S070 2013-11-15 30-day Notice
S069 2013-09-26 30-day Notice
S068 2013-09-26 30-day Notice
S067 2013-08-19 30-day Notice
S066 2013-08-02 30-day Notice
S065 2013-07-01 30-day Notice
S064 2013-04-08 30-day Notice
S063 2013-03-14 Special (immediate Track)
S062 2012-12-17 30-day Notice
S061 2012-03-22 135 Review Track For 30-day Notice
S060 2011-09-26 30-day Notice
S059
S058 2011-08-08 Real-time Process
S057 2011-07-05 30-day Notice
S056 2011-06-29 30-day Notice
S055 2011-04-15 30-day Notice
S054 2011-04-11 Real-time Process
S053 2010-12-20 30-day Notice
S052 2010-12-10 30-day Notice
S051 2010-12-10 135 Review Track For 30-day Notice
S050 2010-11-15 135 Review Track For 30-day Notice
S049 2010-11-01 30-day Notice
S048 2010-10-22 30-day Notice
S047 2010-10-04 30-day Notice
S046 2010-10-01 30-day Notice
S045 2010-10-01 30-day Notice
S044 2010-08-16 30-day Notice
S043 2010-06-04 30-day Notice
S042 2010-03-16 135 Review Track For 30-day Notice
S041 2010-03-16 30-day Notice
S040 2010-03-01 30-day Notice
S039 2010-02-12 Normal 180 Day Track
S038 2009-12-24 135 Review Track For 30-day Notice
S037 2009-11-09 Normal 180 Day Track No User Fee
S036 2009-10-13 30-day Notice
S035 2009-08-28 30-day Notice
S034 2009-03-23 30-day Notice
S033 2009-02-04 30-day Notice
S032 2008-12-22 30-day Notice
S031 2008-12-22 30-day Notice
S030 2008-12-12 30-day Notice
S029 2008-11-17 30-day Notice
S028 2008-11-05 Normal 180 Day Track No User Fee
S027 2008-10-27 30-day Notice
S026 2008-07-16 135 Review Track For 30-day Notice
S025 2008-05-28 135 Review Track For 30-day Notice
S024 2008-05-23 30-day Notice
S023 2008-05-01 Normal 180 Day Track No User Fee
S022 2008-04-21 30-day Notice
S021 2008-03-31 135 Review Track For 30-day Notice
S020 2008-03-31 Normal 180 Day Track
S019 2008-03-24 135 Review Track For 30-day Notice
S018 2008-01-14 30-day Notice
S017
S016 2007-10-09 30-day Notice
S015 2007-08-01 30-day Notice
S014 2007-08-01 30-day Notice
S013 2007-08-01 135 Review Track For 30-day Notice
S012
S011
S010
S009 2007-07-30 30-day Notice
S008 2006-11-27 Special (immediate Track)
S007 2006-10-30 30-day Notice
S006
S005 2006-07-18 30-day Notice
S004 2005-11-30 30-day Notice
S003 2005-08-29 Real-time Process
S002 2004-07-14 Normal 180 Day Track
S001 2004-02-05 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00613994602275 P030009 039
00613994602565 P030009 039
00613994602572 P030009 039
00613994602596 P030009 039
00613994602619 P030009 039
00613994602626 P030009 039
00613994602633 P030009 039
00613994602640 P030009 039
00613994602657 P030009 039
00613994602671 P030009 039
00613994602688 P030009 039
00613994602695 P030009 039
00613994602718 P030009 039
00613994602732 P030009 039
00613994602749 P030009 039
00613994602756 P030009 039
00613994602763 P030009 039
00613994602770 P030009 039
00613994602558 P030009 039
00613994602541 P030009 039
00613994602534 P030009 039
00613994602282 P030009 039
00613994602299 P030009 039
00613994602305 P030009 039
00613994602312 P030009 039
00613994602343 P030009 039
00613994602350 P030009 039
00613994602374 P030009 039
00613994602381 P030009 039
00613994602398 P030009 039
00613994602428 P030009 039
00613994602435 P030009 039
00613994602459 P030009 039
00613994602466 P030009 039
00613994602473 P030009 039
00613994602480 P030009 039
00613994602497 P030009 039
00613994602527 P030009 039
00613994602794 P030009 039
00613994798473 P030009 039
00613994798688 P030009 039
00613994798695 P030009 039
00613994798701 P030009 039
00613994798718 P030009 039
00613994798725 P030009 039
00613994798732 P030009 039
00613994798756 P030009 039
00613994798763 P030009 039
00613994798770 P030009 039
00613994798787 P030009 039
00613994798794 P030009 039
00613994798800 P030009 039
00613994798824 P030009 039
00613994798831 P030009 039
00613994798848 P030009 039
00613994798855 P030009 039
00613994798862 P030009 039
00613994798671 P030009 039
00613994798664 P030009 039
00613994798657 P030009 039
00613994798480 P030009 039
00613994798497 P030009 039
00613994798503 P030009 039
00613994798510 P030009 039
00613994798527 P030009 039
00613994798534 P030009 039
00613994798541 P030009 039
00613994798558 P030009 039
00613994798565 P030009 039
00613994798572 P030009 039
00613994798589 P030009 039
00613994798596 P030009 039
00613994798602 P030009 039
00613994798619 P030009 039
00613994798626 P030009 039
00613994798633 P030009 039
00613994798640 P030009 039
00613994798879 P030009 039

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