P960016S084

None

FDA Premarket Approval P960016 S084

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

DeviceP960016S084
Classification NameNone
Applicant
PMAP960016
SupplementS084

Supplemental Filings

Supplement NumberDateSupplement Type
P960016Original Filing
S085 2020-09-18 30-day Notice
S084
S083 2020-05-06 30-day Notice
S082 2020-03-23 30-day Notice
S081 2020-03-19 30-day Notice
S080 2019-09-26 30-day Notice
S079 2019-06-24 Normal 180 Day Track No User Fee
S078 2019-04-26 30-day Notice
S077 2019-02-14 Normal 180 Day Track No User Fee
S076 2018-12-12 Special (immediate Track)
S075 2018-08-02 30-day Notice
S074 2018-03-05 30-day Notice
S073 2018-03-01 30-day Notice
S072 2018-02-12 30-day Notice
S071 2018-02-05 30-day Notice
S070 2017-10-19 30-day Notice
S069
S068 2017-05-04 30-day Notice
S067 2016-08-12 30-day Notice
S066 2016-06-01 30-day Notice
S065 2016-04-21 30-day Notice
S064 2016-03-22 135 Review Track For 30-day Notice
S063 2016-03-14 30-day Notice
S062 2016-03-09 30-day Notice
S061 2016-02-19 30-day Notice
S060 2015-11-20 Real-time Process
S059 2015-10-30 Normal 180 Day Track No User Fee
S058 2015-10-19 30-day Notice
S057 2015-09-23 30-day Notice
S056 2015-08-21 Normal 180 Day Track No User Fee
S055 2015-06-25 Normal 180 Day Track
S054 2015-04-17 30-day Notice
S053 2015-03-06 30-day Notice
S052 2014-12-22 Special (immediate Track)
S051 2014-12-17 Real-time Process
S050 2014-11-07 Real-time Process
S049 2014-08-27 Real-time Process
S048 2014-08-06 Special (immediate Track)
S047 2014-07-01 Real-time Process
S046 2014-04-30 Normal 180 Day Track No User Fee
S045 2014-03-03 Real-time Process
S044 2013-11-27 Normal 180 Day Track
S043 2013-09-19 135 Review Track For 30-day Notice
S042 2013-02-04 135 Review Track For 30-day Notice
S041 2013-02-01 135 Review Track For 30-day Notice
S040 2012-12-17 Real-time Process
S039 2012-07-23 Real-time Process
S038 2011-11-22 30-day Notice
S037 2011-07-05 30-day Notice
S036 2010-11-10 30-day Notice
S035 2010-10-05 30-day Notice
S034 2010-09-30 Real-time Process
S033 2010-09-27 Real-time Process
S032 2010-08-12 30-day Notice
S031 2010-07-20 30-day Notice
S030 2010-07-14 30-day Notice
S029 2010-05-27 Special (immediate Track)
S028 2010-03-09 30-day Notice
S027 2009-10-30 30-day Notice
S026 2009-10-29 30-day Notice
S025 2009-10-28 30-day Notice
S024 2009-09-02 30-day Notice
S023
S022 2008-01-28 Real-time Process
S021
S020 2007-10-03 Real-time Process
S019 2007-08-07 Real-time Process
S018 2007-04-26 Real-time Process
S017
S016 2006-04-07 Real-time Process
S015
S014 2005-09-09 Normal 180 Day Track
S013 2003-09-10 Special (immediate Track)
S012 2003-07-15 Real-time Process
S011 2003-06-26 135 Review Track For 30-day Notice
S010 2003-03-05 Normal 180 Day Track
S009 2003-02-12 Real-time Process
S008 2002-08-08 Real-time Process
S007 2001-05-14 Normal 180 Day Track
S006 2000-08-22 Normal 180 Day Track
S005 2000-08-18 Normal 180 Day Track
S004 2000-03-30 Normal 180 Day Track
S003 1999-06-28 Normal 180 Day Track
S002 1999-05-20 Normal 180 Day Track
S001 1999-05-06 Real-time Process

NIH GUDID Devices

Device IDPMASupp
05414734200226 P960016 002
05414734217323 P960016 002
05414734200257 P960016 002
05414734200240 P960016 002
05414734200233 P960016 002
05414734200271 P960016 006
05414734200288 P960016 006
05414734200295 P960016 006
05414734200325 P960016 007
05414734200318 P960016 007
05414734200301 P960016 007
05414734205979 P960016 014
05414734205986 P960016 014
05414734205993 P960016 014
05414734206006 P960016 014
05414734206013 P960016 014
05414734206020 P960016 014
05414734217415 P960016 014
05414734217385 P960016 014
05414734217378 P960016 014
05414734206082 P960016 014
05414734206075 P960016 014
05414734206068 P960016 014
05414734206051 P960016 014
05414734206044 P960016 014
05414734206037 P960016 014
05414734217422 P960016 014
05414734217439 P960016 016
05414734217446 P960016 016
05414734217347 P960016 022

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