P980023S099

None

FDA Premarket Approval P980023 S099

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

DeviceP980023S099
Classification NameNone
Applicant
PMAP980023
SupplementS099

Supplemental Filings

Supplement NumberDateSupplement Type
P980023Original Filing
S118 2022-11-30 Normal 180 Day Track No User Fee
S117 2022-11-23 30-day Notice
S116 2022-11-10 30-day Notice
S115 2022-09-22 30-day Notice
S114 2022-06-17 30-day Notice
S113
S112 2022-02-17 30-day Notice
S111
S110 2021-11-23 30-day Notice
S109 2021-09-30 30-day Notice
S108
S107 2021-07-21 30-day Notice
S106 2021-06-21 30-day Notice
S105 2021-03-16 Real-time Process
S104 2020-11-23 30-day Notice
S103 2020-11-02 30-day Notice
S102 2020-08-10 Real-time Process
S101 2020-03-26 30-day Notice
S100
S099
S098
S097 2019-12-31 30-day Notice
S096
S095 2019-09-17 30-day Notice
S094 2019-08-15 Real-time Process
S093 2019-07-01 Real-time Process
S092 2019-04-23 30-day Notice
S091 2019-03-18 30-day Notice
S090 2018-12-11 Normal 180 Day Track No User Fee
S089 2018-11-23 Real-time Process
S088 2018-11-16 30-day Notice
S087
S086 2018-07-10 30-day Notice
S085 2018-06-14 135 Review Track For 30-day Notice
S084 2018-01-22 30-day Notice
S083 2017-11-20 30-day Notice
S082 2017-11-20 Real-time Process
S081 2017-04-12 Real-time Process
S080 2017-03-07 30-day Notice
S079 2016-11-21 30-day Notice
S078 2016-09-23 30-day Notice
S077 2016-08-01 30-day Notice
S076 2016-06-06 Normal 180 Day Track
S075 2016-05-24 Normal 180 Day Track
S074 2015-12-23 Normal 180 Day Track
S073 2015-08-03 30-day Notice
S072 2015-04-16 Normal 180 Day Track
S071 2015-06-19 Real-time Process
S070 2015-06-17 Normal 180 Day Track No User Fee
S069 2015-06-15 30-day Notice
S068 2015-05-27 30-day Notice
S067 2015-05-22 30-day Notice
S066 2015-04-29 135 Review Track For 30-day Notice
S065 2015-03-06 135 Review Track For 30-day Notice
S064 2015-02-04 30-day Notice
S063 2015-01-08 30-day Notice
S062 2014-09-24 30-day Notice
S061 2014-09-19 30-day Notice
S060 2014-07-28 Normal 180 Day Track
S059 2014-06-23 30-day Notice
S058 2014-05-30 30-day Notice
S057 2014-01-27 Normal 180 Day Track
S056 2013-06-14 Real-time Process
S055 2013-04-29 30-day Notice
S054 2013-04-24 135 Review Track For 30-day Notice
S053 2013-04-22 30-day Notice
S052 2013-04-03 Real-time Process
S051 2013-01-14 30-day Notice
S050 2012-12-21 Real-time Process
S049 2012-11-14 Normal 180 Day Track
S048 2012-09-07 30-day Notice
S047 2012-08-29 30-day Notice
S046 2011-11-14 Normal 180 Day Track
S045
S044 2011-04-11 Real-time Process
S043 2010-12-29 Real-time Process
S042
S041 2010-05-28 Normal 180 Day Track No User Fee
S040 2010-04-13 30-day Notice
S039 2010-02-12 30-day Notice
S038 2009-08-19 Normal 180 Day Track
S037 2008-11-20 Real-time Process
S036 2008-11-17 Normal 180 Day Track
S035 2008-10-31 Real-time Process
S034 2008-06-04 135 Review Track For 30-day Notice
S033 2008-05-21 Real-time Process
S032 2008-05-14 Real-time Process
S031 2008-05-14 Normal 180 Day Track
S030 2008-01-07 Real-time Process
S029 2007-07-13 Normal 180 Day Track
S028 2007-06-25 30-day Notice
S027 2006-12-18 Real-time Process
S026 2006-10-12 Real-time Process
S025 2006-09-11 Normal 180 Day Track
S024 2006-06-29 Real-time Process
S023 2006-06-02 Real-time Process
S022 2006-04-10 135 Review Track For 30-day Notice
S021 2006-03-10 Real-time Process
S020 2005-09-06 Normal 180 Day Track
S019 2004-12-19 Normal 180 Day Track
S018 2004-06-14 Real-time Process
S017 2004-04-02 Normal 180 Day Track
S016 2003-09-15 Real-time Process
S015 2003-07-16 Normal 180 Day Track No User Fee
S014 2003-03-10 Normal 180 Day Track
S013 2003-02-19 Normal 180 Day Track
S012 2003-01-27 Normal 180 Day Track
S011 2002-11-20 30-day Notice
S010 2002-07-22 Real-time Process
S009 2002-06-04 Normal 180 Day Track
S008 2002-04-08 Real-time Process
S007 2002-01-22 Normal 180 Day Track
S006 2002-02-04 Real-time Process
S005 2001-06-25 Normal 180 Day Track
S004 2001-04-27 Normal 180 Day Track
S003 1999-11-02 Normal 180 Day Track
S002 1999-06-01 Real-time Process
S001 1999-02-22 Real-time Process

NIH GUDID Devices

Device IDPMASupp
04035479009335 P980023 000
04035479005221 P980023 000
04035479005641 P980023 000
04035479000455 P980023 000
04035479006211 P980023 000
04035479006051 P980023 000
04035479011987 P980023 009
04035479100391 P980023 038
04035479100476 P980023 038
04035479100469 P980023 038
04035479100414 P980023 038
04035479100407 P980023 038
04035479100384 P980023 038
04035479116194 P980023 043
04035479112998 P980023 043
04035479112981 P980023 043
04035479112974 P980023 043
04035479143121 P980023 046
04035479143442 P980023 046
04035479143138 P980023 046
04035479143435 P980023 046
04035479143428 P980023 046
04035479143411 P980023 046
04035479143404 P980023 046
04035479143398 P980023 046
04035479143374 P980023 046
04035479143367 P980023 046
04035479143145 P980023 046
04035479143459 P980023 046
04035479143466 P980023 046
04035479143381 P980023 046
04035479132644 P980023 057
04035479100513 P980023 057
04035479121471 P980023 057
04035479121488 P980023 057
04035479121495 P980023 057
04035479132613 P980023 057
04035479121686 P980023 057
04035479136093 P980023 057
04035479136109 P980023 057
04035479136116 P980023 057
04035479136123 P980023 057
04035479100506 P980023 057
04035479119751 P980023 057
04035479100490 P980023 057
04035479121709 P980023 057
04035479151157 P980023 070
04035479151065 P980023 070
04035479151072 P980023 070
04035479151089 P980023 070
04035479151096 P980023 070
04035479151102 P980023 070
04035479151119 P980023 070
04035479151126 P980023 070
04035479151133 P980023 070
04035479151164 P980023 070
04035479151140 P980023 070
04035479151058 P980023 070
04035479151041 P980023 070
04035479151027 P980023 075
04035479140007 P980023 075
04035479139995 P980023 075
04035479138516 P980023 075
04035479138523 P980023 075
04035479140021 P980023 075
04035479151034 P980023 075
04035479133139 P980023 075
04035479140038 P980023 075
04035479151003 P980023 075
04035479150976 P980023 082
04035479150969 P980023 082
04035479158781 P980023 089
04035479158798 P980023 089
04035479150952 P980023 099
04035479140014 P980023 099
04035479139971 P980023 099
04035479150983 P980023 099
04035479156459 P980023 113
04035479156466 P980023 113
04035479156473 P980023 113
04035479156480 P980023 113
04035479156497 P980023 113
04035479156503 P980023 113
04035479156510 P980023 113
04035479156527 P980023 113
04035479156442 P980023 113

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.