P000058S018

None

FDA Premarket Approval P000058 S018

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

DeviceP000058S018
Classification NameNone
Applicant
PMAP000058
SupplementS018

Supplemental Filings

Supplement NumberDateSupplement Type
P000058Original Filing
S087 2022-07-21 30-day Notice
S086 2022-05-10 30-day Notice
S085 2022-01-20 30-day Notice
S084 2021-03-09 30-day Notice
S083 2021-01-15 30-day Notice
S082 2020-07-30 30-day Notice
S081
S080
S079
S078 2020-06-11 30-day Notice
S077 2019-11-04 30-day Notice
S076 2019-10-31 30-day Notice
S075 2019-09-25 30-day Notice
S074
S073
S072 2019-06-28 30-day Notice
S071 2018-10-17 Normal 180 Day Track
S070 2018-10-02 30-day Notice
S069 2018-08-02 30-day Notice
S068 2017-11-13 30-day Notice
S067 2017-05-23 30-day Notice
S066
S065 2017-04-28 Normal 180 Day Track
S064 2017-02-03 30-day Notice
S063 2017-01-23 30-day Notice
S062 2016-08-31 30-day Notice
S061 2016-07-11 30-day Notice
S060 2016-06-21 Normal 180 Day Track
S059 2015-04-13 Normal 180 Day Track
S058 2014-10-29 Real-time Process
S057 2014-10-27 Normal 180 Day Track No User Fee
S056 2014-01-27 Normal 180 Day Track
S055
S054 2013-10-25 Real-time Process
S053 2013-02-26 30-day Notice
S052 2013-01-14 30-day Notice
S051 2012-12-21 30-day Notice
S050 2012-08-21 135 Review Track For 30-day Notice
S049 2011-12-19 Normal 180 Day Track
S048 2011-10-20 Special (immediate Track)
S047 2011-10-04 135 Review Track For 30-day Notice
S046 2011-08-26 Real-time Process
S045 2011-08-19 Special (immediate Track)
S044 2011-06-16 135 Review Track For 30-day Notice
S043 2011-02-15 135 Review Track For 30-day Notice
S042 2011-01-13 30-day Notice
S041 2010-09-30 135 Review Track For 30-day Notice
S040 2010-09-30 135 Review Track For 30-day Notice
S039 2010-09-01 Normal 180 Day Track No User Fee
S038 2010-06-03 135 Review Track For 30-day Notice
S037 2010-05-14 Normal 180 Day Track No User Fee
S036 2010-02-24 Special (immediate Track)
S035
S034 2009-09-01 135 Review Track For 30-day Notice
S033 2009-03-25 135 Review Track For 30-day Notice
S032 2009-03-16 Special (immediate Track)
S031 2008-12-23 Real-time Process
S030 2008-11-21 135 Review Track For 30-day Notice
S029 2008-08-29 135 Review Track For 30-day Notice
S028 2008-01-14 135 Review Track For 30-day Notice
S027 2007-11-16 Normal 180 Day Track No User Fee
S026 2007-11-06 Normal 180 Day Track No User Fee
S025 2007-07-31 135 Review Track For 30-day Notice
S024
S023 2007-04-06 135 Review Track For 30-day Notice
S022 2007-03-05 Normal 180 Day Track
S021 2006-12-22 135 Review Track For 30-day Notice
S020 2006-10-27 Normal 180 Day Track
S019 2006-10-12 Special (immediate Track)
S018
S017 2005-02-22 Real-time Process
S016 2005-02-04 135 Review Track For 30-day Notice
S015 2004-11-15 Real-time Process
S014 2004-09-17 135 Review Track For 30-day Notice
S013
S012
S011
S010 2004-05-20 Real-time Process
S009 2004-04-20 Real-time Process
S008 2004-03-19 Special (immediate Track)
S007 2004-03-04 Special (immediate Track)
S006 2003-08-26 Normal 180 Day Track No User Fee
S005 2003-08-22 Normal 180 Day Track No User Fee
S004 2003-07-01 Normal 180 Day Track
S003 2002-12-16 Normal 180 Day Track
S002
S001

NIH GUDID Devices

Device IDPMASupp
00681490843829 P000058 000
00681490843812 P000058 000
00681490843805 P000058 000
00681490843782 P000058 000
00613994239525 P000058 022
00613994239518 P000058 022
00673978783741 P000058 059
00673978072319 P000058 059
00673978072289 P000058 059
00673978072265 P000058 059
00673978072241 P000058 059
00673978783758 P000058 059
00673978783765 P000058 059
00673978783772 P000058 059
00673978783789 P000058 059
00673978783796 P000058 059
00673978783802 P000058 059
00673978955766 P000058 059
00673978072227 P000058 059
00673978072203 P000058 059
00673978071961 P000058 059
00673978071985 P000058 059
00673978072005 P000058 059
00673978072029 P000058 059
00673978072043 P000058 059
00673978072067 P000058 059
00673978072081 P000058 059
00673978072104 P000058 059
00673978072128 P000058 059
00673978072142 P000058 059
00673978072166 P000058 059
00673978072180 P000058 059
00673978955773 P000058 059
00673978955780 P000058 059
00673978955803 P000058 059
00673978957487 P000058 059
00673978957494 P000058 059
00673978957500 P000058 059
00673978957517 P000058 059
00673978957524 P000058 059
00673978957531 P000058 059
00673978957548 P000058 059
00673978957555 P000058 059
00673978957562 P000058 059
00673978957579 P000058 059
00681490499682 P000058 059
00673978957470 P000058 059
00673978957463 P000058 059
00673978957456 P000058 059
00673978957340 P000058 059
00673978957357 P000058 059
00673978957364 P000058 059
00673978957371 P000058 059
00673978957388 P000058 059
00673978957395 P000058 059
00673978957401 P000058 059
00673978957418 P000058 059
00673978957425 P000058 059
00673978957432 P000058 059
00673978957449 P000058 059
00681490499699 P000058 059

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