P970004S299

None

FDA Premarket Approval P970004 S299

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

DeviceP970004S299
Classification NameNone
Applicant
PMAP970004
SupplementS299

Supplemental Filings

Supplement NumberDateSupplement Type
P970004Original Filing
S301 2019-09-16 30-day Notice
S300 2019-09-12 Special (immediate Track)
S299
S298 2019-08-29 30-day Notice
S297 2019-08-19 30-day Notice
S296 2019-07-29 30-day Notice
S295 2019-07-16 30-day Notice
S294
S293 2019-06-26 Special (immediate Track)
S292
S291 2019-06-06 30-day Notice
S290 2019-05-06 30-day Notice
S289 2019-04-26 30-day Notice
S288 2019-04-24 30-day Notice
S287 2019-04-17 30-day Notice
S286 2019-04-01 30-day Notice
S285 2019-03-07 30-day Notice
S284
S283 2019-02-21 30-day Notice
S282 2018-12-26 Real-time Process
S281 2018-12-11 30-day Notice
S280 2018-11-06 30-day Notice
S279 2018-10-19 30-day Notice
S278 2018-09-10 30-day Notice
S277 2018-08-02 30-day Notice
S276 2018-07-17 30-day Notice
S275 2018-06-18 30-day Notice
S274 2018-05-18 30-day Notice
S273 2018-05-16 30-day Notice
S272 2018-05-07 30-day Notice
S271 2018-05-02 30-day Notice
S270 2018-04-26 30-day Notice
S269 2018-04-16 30-day Notice
S268 2018-04-04 Normal 180 Day Track
S267 2018-03-14 30-day Notice
S266 2018-03-12 30-day Notice
S265 2018-01-05 135 Review Track For 30-day Notice
S264 2017-11-20 30-day Notice
S263
S262 2017-11-13 30-day Notice
S261 2017-11-08 Real-time Process
S260 2017-10-20 30-day Notice
S259 2017-10-10 30-day Notice
S258 2017-09-27 30-day Notice
S257 2017-09-13 30-day Notice
S256 2017-09-05 Normal 180 Day Track No User Fee
S255 2017-08-28 30-day Notice
S254 2017-08-22 135 Review Track For 30-day Notice
S253 2017-08-21 Normal 180 Day Track No User Fee
S252 2017-08-03 135 Review Track For 30-day Notice
S251 2017-07-27 30-day Notice
S250 2017-07-17 30-day Notice
S249 2017-07-17 Real-time Process
S248 2017-07-17 30-day Notice
S247 2017-06-27 Normal 180 Day Track
S246 2017-06-16 30-day Notice
S245 2017-05-18 30-day Notice
S244 2017-05-12 30-day Notice
S243 2017-05-03 30-day Notice
S242 2017-04-28 30-day Notice
S241 2017-04-26 30-day Notice
S240 2017-04-03 30-day Notice
S239 2017-03-29 30-day Notice
S238 2017-03-09 30-day Notice
S237 2017-01-13 30-day Notice
S236 2017-01-11 30-day Notice
S235 2017-01-09 30-day Notice
S234 2016-12-19 30-day Notice
S233 2016-11-23 30-day Notice
S232 2016-11-21 30-day Notice
S231 2016-11-14 30-day Notice
S230 2016-10-18 30-day Notice
S229 2016-09-28 30-day Notice
S228 2016-08-25 Real-time Process
S227 2016-08-15 30-day Notice
S226 2016-08-15 30-day Notice
S225 2016-08-15 Real-time Process
S224 2016-08-12 30-day Notice
S223 2016-08-01 30-day Notice
S222 2016-07-25 30-day Notice
S221 2016-07-08 Special (immediate Track)
S220 2016-06-27 30-day Notice
S219 2016-06-27 30-day Notice
S218 2016-06-21 Normal 180 Day Track No User Fee
S217 2016-06-16 30-day Notice
S216 2016-06-09 30-day Notice
S215 2016-06-07 30-day Notice
S214 2016-06-06 30-day Notice
S213 2016-05-12 30-day Notice
S212 2016-04-05 30-day Notice
S211 2016-03-04 30-day Notice
S210 2016-02-08 Normal 180 Day Track
S209 2015-12-28 30-day Notice
S208 2015-11-23 30-day Notice
S207 2015-10-29 30-day Notice
S206 2015-10-13 30-day Notice
S205 2015-09-30 30-day Notice
S204 2015-08-31 135 Review Track For 30-day Notice
S203 2015-08-13 30-day Notice
S202 2015-06-17 30-day Notice
S201 2015-06-16 30-day Notice
S200 2015-06-11 30-day Notice
S199 2015-06-01 30-day Notice
S198 2015-04-28 30-day Notice
S197 2015-04-20 Normal 180 Day Track No User Fee
S196 2015-03-19 30-day Notice
S195 2015-03-06 30-day Notice
S194 2015-03-03 30-day Notice
S193 2015-02-27 30-day Notice
S192 2015-02-27 30-day Notice
S191
S190 2015-02-04 30-day Notice
S189 2015-01-12 30-day Notice
S188 2015-01-09 30-day Notice
S187 2014-12-29 Normal 180 Day Track
S186 2014-11-24 30-day Notice
S185 2014-09-16 30-day Notice
S184 2014-09-04 30-day Notice
S183 2014-08-25 30-day Notice
S182 2014-08-01 30-day Notice
S181 2014-07-30 30-day Notice
S180 2014-07-03 30-day Notice
S179 2014-06-30 30-day Notice
S178 2014-06-27 Special (immediate Track)
S177 2014-06-04 30-day Notice
S176 2014-06-02 30-day Notice
S175 2014-05-30 30-day Notice
S174 2014-05-22 30-day Notice
S173 2014-05-12 30-day Notice
S172 2014-04-21 Normal 180 Day Track
S171 2014-03-28 30-day Notice
S170 2014-03-13 30-day Notice
S169 2014-03-13 30-day Notice
S168 2014-03-07 30-day Notice
S167 2014-02-04 135 Review Track For 30-day Notice
S166 2013-12-23 30-day Notice
S165 2013-11-13 30-day Notice
S164 2013-10-25 30-day Notice
S163 2013-09-30 30-day Notice
S162 2013-09-24 30-day Notice
S161 2013-09-23 30-day Notice
S160 2013-09-23 30-day Notice
S159 2013-09-13 30-day Notice
S158 2013-09-09 30-day Notice
S157 2013-07-12 30-day Notice
S156 2013-05-31 135 Review Track For 30-day Notice
S155 2013-04-26 Normal 180 Day Track
S154 2013-03-18 30-day Notice
S153 2013-03-07 Normal 180 Day Track No User Fee
S152 2013-02-11 Real-time Process
S151 2013-02-08 135 Review Track For 30-day Notice
S150 2013-02-06 Normal 180 Day Track
S149 2013-01-22 30-day Notice
S148 2013-01-17 30-day Notice
S147 2012-12-11 30-day Notice
S146 2012-11-13 135 Review Track For 30-day Notice
S145
S144 2012-10-04 30-day Notice
S143 2012-09-25 30-day Notice
S142 2012-09-10 30-day Notice
S141 2012-09-06 Normal 180 Day Track No User Fee
S140 2012-08-20 30-day Notice
S139 2012-07-25 30-day Notice
S138 2012-07-23 135 Review Track For 30-day Notice
S137 2012-07-13 30-day Notice
S136 2012-05-09 30-day Notice
S135 2012-05-09 30-day Notice
S134 2012-05-07 30-day Notice
S133 2012-04-10 30-day Notice
S132 2012-03-26 30-day Notice
S131 2012-03-22 30-day Notice
S130 2012-03-16 30-day Notice
S129 2012-01-09 30-day Notice
S128 2011-12-21 30-day Notice
S127 2011-12-16 30-day Notice
S126 2011-12-08 30-day Notice
S125 2011-07-29 Special (immediate Track)
S124 2011-07-25 Normal 180 Day Track
S123 2011-07-22 30-day Notice
S122 2011-07-19 30-day Notice
S121 2011-07-12 Normal 180 Day Track No User Fee
S120 2011-07-06 30-day Notice
S119 2011-06-29 30-day Notice
S118 2011-06-10 30-day Notice
S117 2011-06-06 30-day Notice
S116 2011-05-25 Special (immediate Track)
S115 2011-05-23 30-day Notice
S114 2011-05-20 30-day Notice
S113 2011-05-18 30-day Notice
S112 2011-04-18 135 Review Track For 30-day Notice
S111 2011-04-08 30-day Notice
S110 2011-04-04 30-day Notice
S109 2011-03-16 135 Review Track For 30-day Notice
S108 2011-03-14 135 Review Track For 30-day Notice
S107 2011-02-16 30-day Notice
S106 2011-02-07 30-day Notice
S105 2011-02-07 30-day Notice
S104 2011-02-03 Real-time Process
S103 2010-12-08 30-day Notice
S102 2010-12-07 30-day Notice
S101 2010-11-30 30-day Notice
S100 2010-11-24 30-day Notice
S099 2010-11-22 30-day Notice
S098 2010-11-12 Real-time Process
S097 2010-10-25 30-day Notice
S096 2010-10-12 30-day Notice
S095 2010-10-06 30-day Notice
S094
S093 2010-09-14 30-day Notice
S092 2010-08-31 30-day Notice
S091 2010-08-11 30-day Notice
S090 2010-06-30 30-day Notice
S089 2010-06-28 30-day Notice
S088 2010-06-22 30-day Notice
S087 2010-08-24 Normal 180 Day Track
S086 2010-06-01 30-day Notice
S085 2010-04-20 30-day Notice
S084 2010-04-02 30-day Notice
S083 2010-03-19 30-day Notice
S082 2010-02-02 Normal 180 Day Track No User Fee
S081 2010-02-01 30-day Notice
S080 2010-01-27 30-day Notice
S079 2010-01-26 Real-time Process
S078 2010-01-12 30-day Notice
S077 2010-01-07 Real-time Process
S076 2009-12-14 30-day Notice
S075 2009-08-24 Normal 180 Day Track No User Fee
S074 2009-05-18 30-day Notice
S073 2009-04-28 Normal 180 Day Track
S072 2009-04-14 30-day Notice
S071 2009-02-12 30-day Notice
S070 2009-02-06 30-day Notice
S069 2009-01-14 Real-time Process
S068 2009-01-02 30-day Notice
S067 2008-12-17 30-day Notice
S066 2008-12-15 30-day Notice
S065 2008-12-11 Normal 180 Day Track No User Fee
S064 2008-11-03 Normal 180 Day Track
S063 2008-10-29 30-day Notice
S062 2008-09-16 Real-time Process
S061
S060 2008-07-24 135 Review Track For 30-day Notice
S059
S058
S057 2008-06-02 30-day Notice
S056 2008-05-12 Real-time Process
S055 2008-04-23 30-day Notice
S054 2008-04-02 Real-time Process
S053 2008-03-26 30-day Notice
S052 2008-03-20 30-day Notice
S051 2008-03-11 30-day Notice
S050 2008-03-10 135 Review Track For 30-day Notice
S049 2008-02-26 Real-time Process
S048 2008-02-25 30-day Notice
S047 2007-12-21 30-day Notice
S046 2007-11-23 30-day Notice
S045 2007-11-19 30-day Notice
S044 2007-10-09 30-day Notice
S043 2007-09-17 Special (immediate Track)
S042 2007-09-17 135 Review Track For 30-day Notice
S041 2007-08-31 Real-time Process
S040 2007-01-12 Normal 180 Day Track No User Fee
S039 2006-05-15 Real-time Process
S038
S037 2006-03-06 Normal 180 Day Track No User Fee
S036 2005-10-17 30-day Notice
S035 2005-11-28 Real-time Process
S034 2005-10-06 135 Review Track For 30-day Notice
S033 2005-09-30 Normal 180 Day Track
S032 2005-05-12 Special (immediate Track)
S031
S030 2004-08-30 Normal 180 Day Track No User Fee
S029 2004-08-30 Normal 180 Day Track
S028 2004-05-12 30-day Notice
S027 2004-01-02 Special (immediate Track)
S026 2003-08-22 Normal 180 Day Track No User Fee
S025 2003-06-02 Normal 180 Day Track No User Fee
S024 2003-03-07 Real-time Process
S023 2002-07-31 Normal 180 Day Track
S022 2002-03-07 Normal 180 Day Track
S021 2002-01-17 Real-time Process
S020 2002-01-16 Real-time Process
S019 2001-11-15 30-day Notice
S018 2001-11-05 Special (immediate Track)
S017 2001-10-17 Normal 180 Day Track
S016 2001-06-25 Normal 180 Day Track
S015 2001-05-25 Special (immediate Track)
S014 2001-04-27 Normal 180 Day Track
S013 2001-02-22 Normal 180 Day Track
S012 2001-02-20 Normal 180 Day Track
S011 2001-01-22 Real-time Process
S010 2000-06-20 Real-time Process
S009 2000-04-21 Normal 180 Day Track
S008 2000-02-29 Real-time Process
S007 2000-02-15 Real-time Process
S006 1999-10-28 Real-time Process
S005 1999-08-25 Real-time Process
S004 1998-10-21 Panel Track
S003 1998-08-03 Normal 180 Day Track
S002 1998-02-27 Normal 180 Day Track
S001 1997-10-29 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00613994164049 P970004 000
20613994145066 P970004 000
00613994164049 P970004 000
00613994141996 P970004 000
20613994164005 P970004 000
20613994145066 P970004 000
20613994164005 P970004 000
00613994141996 P970004 000
20613994163978 P970004 001
20613994163978 P970004 001
00613994100894 P970004 002
00613994100870 P970004 002
00613994100856 P970004 002
00613994100894 P970004 002
00613994287731 P970004 002
00613994287731 P970004 002
00613994100870 P970004 002
00613994100856 P970004 002
00613994100979 P970004 004
00613994100955 P970004 004
00613994100931 P970004 004
00613994100931 P970004 004
00613994100955 P970004 004
00613994100979 P970004 004
00613994287724 P970004 033
00613994287724 P970004 033
00613994431707 P970004 056
00613994431707 P970004 056
00613994572059 P970004 062
00613994572059 P970004 062
00613994572783 P970004 062
00613994572783 P970004 062
00613994601926 P970004 073
00613994601933 P970004 073
00613994601957 P970004 073
00613994601964 P970004 073
00613994601940 P970004 073
00613994601926 P970004 073
00613994601964 P970004 073
00613994601933 P970004 073
00613994601940 P970004 073
00613994601957 P970004 073
20613994729945 P970004 079
20613994729921 P970004 079
20613994729945 P970004 079
20613994729921 P970004 079
00613994606846 P970004 098
00613994606846 P970004 098
00643169512955 P970004 172
00643169518940 P970004 172
00643169518940 P970004 172
00643169512955 P970004 172
00643169887923 P970004 231
00643169887923 P970004 231
00643169887930 P970004 233
00643169887930 P970004 233
00643169021440 P970004 234
00643169021440 P970004 234
00643169781863 P970004 234
00643169781863 P970004 234
00643169887947 P970004 239
00643169887947 P970004 239
00643169928992 P970004 246
00643169929005 P970004 246
00643169928992 P970004 246
00643169929005 P970004 246
00643169860728 P970004 248
00643169860728 P970004 248

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