P930039S212

None

FDA Premarket Approval P930039 S212

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

• Device: P930039S212
• Classification Name: None
• PMA: P930039
• Supplement: S212

Supplemental Filings

Supplement Number	Date	Supplement Type
P930039		Original Filing
S248	2023-01-09	30-day Notice
S247	2022-11-16	30-day Notice
S246	2022-10-19	30-day Notice
S245	2022-09-13	30-day Notice
S244	2022-06-17	Normal 180 Day Track No User Fee
S243	2022-05-20	30-day Notice
S242	2022-05-10	30-day Notice
S241	2022-04-14	30-day Notice
S240	2022-03-21	30-day Notice
S239	2022-02-23	30-day Notice
S238
S237	2022-01-28	30-day Notice
S236	2022-01-13	30-day Notice
S235	2021-11-19	30-day Notice
S234
S233
S232	2021-09-24	30-day Notice
S231	2021-09-23	30-day Notice
S230	2021-08-20	30-day Notice
S229	2021-08-09	30-day Notice
S228	2021-06-15	30-day Notice
S227	2021-05-03	30-day Notice
S226	2021-04-28	30-day Notice
S225	2021-04-20	30-day Notice
S224	2021-03-19	30-day Notice
S223	2021-02-05	30-day Notice
S222	2020-12-08	30-day Notice
S221	2020-12-07	30-day Notice
S220
S219	2020-12-01	30-day Notice
S218
S217	2020-10-23	30-day Notice
S216	2020-10-15	30-day Notice
S215	2020-09-17	30-day Notice
S214	2020-07-09	30-day Notice
S213	2020-07-08	30-day Notice
S212
S211	2020-03-23	Real-time Process
S210	2020-02-20	30-day Notice
S209	2020-01-31	30-day Notice
S208	2019-11-18	30-day Notice
S207	2019-11-18	30-day Notice
S206
S205	2019-11-12	30-day Notice
S204	2019-09-11	30-day Notice
S203	2019-07-01	30-day Notice
S202
S201	2019-06-20	30-day Notice
S200	2019-06-18	30-day Notice
S199	2019-06-10	30-day Notice
S198	2019-05-29	30-day Notice
S197	2019-05-02	Normal 180 Day Track No User Fee
S196	2019-02-28	30-day Notice
S195	2018-11-21	30-day Notice
S194
S193	2018-10-23	30-day Notice
S192	2018-10-18	30-day Notice
S191	2018-09-26	30-day Notice
S190	2018-06-20	30-day Notice
S189	2018-06-01	30-day Notice
S188	2018-05-15	30-day Notice
S187	2018-05-11	30-day Notice
S186	2018-04-13	Normal 180 Day Track
S185	2018-04-09	30-day Notice
S184	2018-04-06	30-day Notice
S183	2018-03-28	30-day Notice
S182	2018-03-16	30-day Notice
S181	2018-03-06	30-day Notice
S180	2018-02-22	30-day Notice
S179	2017-12-04	Real-time Process
S178	2017-11-20	30-day Notice
S177	2017-10-20	30-day Notice
S176	2017-10-13	30-day Notice
S175	2017-08-07	30-day Notice
S174	2017-06-28	30-day Notice
S173	2017-06-23	30-day Notice
S172	2017-06-07	30-day Notice
S171	2017-06-02	30-day Notice
S170	2017-05-18	Normal 180 Day Track
S169	2017-04-03	Normal 180 Day Track
S168	2017-01-25	Real-time Process
S167	2017-01-24	30-day Notice
S166	2016-12-06	Normal 180 Day Track
S165	2016-12-06	Normal 180 Day Track
S164	2016-11-28	30-day Notice
S163	2016-11-14	30-day Notice
S162	2016-11-02	Normal 180 Day Track
S161	2016-10-05	30-day Notice
S160	2016-09-23	30-day Notice
S159	2016-09-12	30-day Notice
S158	2016-09-02	30-day Notice
S157	2016-08-29	30-day Notice
S156	2016-08-25	30-day Notice
S155	2016-08-02	30-day Notice
S154	2016-07-26	30-day Notice
S153	2016-06-24	30-day Notice
S152	2016-05-03	Normal 180 Day Track
S151	2016-04-15	Normal 180 Day Track
S150	2016-03-23	30-day Notice
S149	2016-03-11	Normal 180 Day Track
S148	2016-03-01	Normal 180 Day Track
S147	2015-12-28	30-day Notice
S146	2015-12-28	30-day Notice
S145	2015-12-22	30-day Notice
S144	2015-12-04	30-day Notice
S143	2015-10-23	30-day Notice
S142	2015-10-13	Normal 180 Day Track
S141	2015-09-30	30-day Notice
S140	2015-09-24	Normal 180 Day Track
S139	2015-09-17	30-day Notice
S138	2015-03-16	Normal 180 Day Track
S137	2015-09-10	30-day Notice
S136	2015-07-20	30-day Notice
S135	2015-07-01	30-day Notice
S134	2015-06-19	30-day Notice
S133	2015-06-18	30-day Notice
S132	2015-05-18	30-day Notice
S131	2015-05-18	30-day Notice
S130	2015-04-20	Normal 180 Day Track
S129	2015-04-17	30-day Notice
S128	2015-04-16	30-day Notice
S127	2015-03-26	30-day Notice
S126	2015-02-26	30-day Notice
S125	2015-02-09	30-day Notice
S124	2015-01-21	30-day Notice
S123	2014-12-08	Normal 180 Day Track
S122	2014-12-08	30-day Notice
S121	2014-09-29	30-day Notice
S120	2014-09-26	30-day Notice
S119	2014-09-15	30-day Notice
S118	2014-08-27	30-day Notice
S117	2014-08-27	30-day Notice
S116	2014-08-12	30-day Notice
S115	2014-08-08	30-day Notice
S114	2014-07-28	30-day Notice
S113	2014-07-24	30-day Notice
S112	2014-07-11	30-day Notice
S111	2014-06-19	30-day Notice
S110	2014-06-16	30-day Notice
S109	2014-05-22	30-day Notice
S108	2014-05-12	30-day Notice
S107	2014-04-17	Normal 180 Day Track
S106	2014-03-07	30-day Notice
S105	2014-02-27	30-day Notice
S104	2014-01-29	30-day Notice
S103	2014-01-22	30-day Notice
S102	2013-12-24	30-day Notice
S101	2013-12-19	30-day Notice
S100	2013-12-17	30-day Notice
S099
S098	2013-12-12	30-day Notice
S097	2013-11-27	30-day Notice
S096	2013-10-30	30-day Notice
S095	2013-10-24	30-day Notice
S094	2013-09-30	30-day Notice
S093	2013-09-17	30-day Notice
S092	2013-06-07	30-day Notice
S091
S090	2013-05-21	30-day Notice
S089	2013-05-17	Real-time Process
S088	2013-04-30	30-day Notice
S087	2013-04-25	30-day Notice
S086
S085	2013-04-09	Normal 180 Day Track No User Fee
S084	2013-03-22	30-day Notice
S083	2013-03-20	30-day Notice
S082	2013-01-14	30-day Notice
S081	2012-12-17	30-day Notice
S080	2012-12-10	30-day Notice
S079	2012-11-29	30-day Notice
S078	2012-11-21	30-day Notice
S077	2012-11-01	30-day Notice
S076	2012-10-22	30-day Notice
S075	2012-09-28	30-day Notice
S074	2012-09-21	30-day Notice
S073	2012-09-04	30-day Notice
S072	2012-08-31	Normal 180 Day Track No User Fee
S071	2012-08-03	30-day Notice
S070	2012-07-18	30-day Notice
S069	2012-07-13	30-day Notice
S068	2012-06-11	30-day Notice
S067	2012-03-09	30-day Notice
S066	2012-02-29	30-day Notice
S065	2011-11-25	30-day Notice
S064	2011-11-21	Normal 180 Day Track
S063	2011-10-24	135 Review Track For 30-day Notice
S062	2011-08-12	30-day Notice
S061	2011-07-18	30-day Notice
S060	2011-07-08	30-day Notice
S059	2011-06-28	30-day Notice
S058	2011-06-27	30-day Notice
S057	2011-06-08	30-day Notice
S056	2011-06-08	135 Review Track For 30-day Notice
S055	2011-06-01	30-day Notice
S054
S053	2011-05-13	30-day Notice
S052	2011-04-26	30-day Notice
S051	2011-04-22	30-day Notice
S050	2011-03-22	135 Review Track For 30-day Notice
S049	2011-03-18	135 Review Track For 30-day Notice
S048	2011-02-28	30-day Notice
S047	2010-11-12	30-day Notice
S046	2010-10-26	30-day Notice
S045	2010-09-29	30-day Notice
S044
S043	2010-07-28	30-day Notice
S042	2010-07-15	30-day Notice
S041	2010-07-15	30-day Notice
S040	2010-07-15	30-day Notice
S039	2010-06-28	135 Review Track For 30-day Notice
S038
S037	2010-04-19	30-day Notice
S036	2010-03-29	30-day Notice
S035	2010-01-19	30-day Notice
S034	2009-10-09	30-day Notice
S033	2009-10-08	Real-time Process
S032	2009-04-10	30-day Notice
S031	2009-03-17	Real-time Process
S030	2009-02-05	30-day Notice
S029	2008-12-11	30-day Notice
S028
S027	2008-04-23	135 Review Track For 30-day Notice
S026	2008-03-24	30-day Notice
S025	2008-03-10	135 Review Track For 30-day Notice
S024	2008-01-04	30-day Notice
S023	2007-06-27	30-day Notice
S022	2007-05-18	30-day Notice
S021
S020	2004-09-10	Normal 180 Day Track
S019	2004-03-01	135 Review Track For 30-day Notice
S018	2004-02-10	30-day Notice
S017	2003-11-13	Real-time Process
S016	2003-07-02	Real-time Process
S015	2003-03-04	30-day Notice
S014	2002-12-24	Real-time Process
S013	2001-11-14	Real-time Process
S012	2001-11-05	Special (immediate Track)
S011
S010	2001-07-17	30-day Notice
S009	2000-03-13	Normal 180 Day Track
S008	2000-01-11	30-day Notice
S007	2000-01-05	30-day Notice
S006	1998-04-20
S005	1998-03-02	Normal 180 Day Track
S004	1997-11-17	Normal 180 Day Track
S003	1996-11-21	Normal 180 Day Track
S002	1996-06-24	Normal 180 Day Track
S001	1996-05-02	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00885074248592	P930039	002
00885074311883	P930039	004
00885074311876	P930039	004
00885074311869	P930039	004
00681490124867	P930039	009
00681490124812	P930039	009
00681490730068	P930039	009
00721902309656	P930039	009
00681490124799	P930039	009
00681490730099	P930039	009
00681490729963	P930039	009
00885074248448	P930039	014
00885074200675	P930039	017
00885074200699	P930039	017
00885074200682	P930039	017
00613994329387	P930039	017
00613994329394	P930039	017
00613994329400	P930039	017
00613994776853	P930039	020
00613994776822	P930039	020
00643169448926	P930039	107
00643169448919	P930039	107
00643169448902	P930039	107
00643169448896	P930039	107
00643169448889	P930039	107
00643169448872	P930039	107
00643169550803	P930039	115
00643169550742	P930039	115
00643169550759	P930039	115
00643169550766	P930039	115
00643169550872	P930039	115
00643169550865	P930039	115
00643169550858	P930039	115
00643169550841	P930039	115
00643169550834	P930039	115
00643169550827	P930039	115
00643169550773	P930039	115
00643169550780	P930039	115
00643169550797	P930039	115
00643169550810	P930039	115
00643169633780	P930039	123
00643169633759	P930039	123
00763000014681	P930039	123
00643169633773	P930039	123
00763000014704	P930039	123
00763000014711	P930039	123
00763000014728	P930039	123
00643169453180	P930039	123
00643169633735	P930039	123
00763000014698	P930039	123
00643169633766	P930039	123
00643169633742	P930039	123
00643169708228	P930039	149
00643169708211	P930039	149
00643169708198	P930039	149
00643169708181	P930039	149
00643169708174	P930039	149
00763000014674	P930039	149
00643169708204	P930039	149
00763000014643	P930039	149
00763000014650	P930039	149
00763000014667	P930039	149
00763000014636	P930039	149