P970051S193

None

FDA Premarket Approval P970051 S193

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: P970051S193
• Classification Name: None
• PMA: P970051
• Supplement: S193

Supplemental Filings

Supplement Number	Date	Supplement Type
P970051		Original Filing
S216	2022-11-21	Normal 180 Day Track No User Fee
S215	2022-11-14	30-day Notice
S214	2022-09-07	Real-time Process
S213	2022-07-11	30-day Notice
S212
S211
S210	2022-02-08	Normal 180 Day Track No User Fee
S209	2022-02-01	30-day Notice
S208
S207	2021-07-13	Real-time Process
S206
S205
S204	2021-02-24	30-day Notice
S203
S202	2020-11-18	30-day Notice
S201	2020-11-12	30-day Notice
S200
S199	2020-07-15	30-day Notice
S198	2020-04-16	Normal 180 Day Track No User Fee
S197
S196	2020-02-21	30-day Notice
S195	2020-01-14	Special (immediate Track)
S194	2019-11-13	30-day Notice
S193
S192	2019-09-09	30-day Notice
S191
S190
S189	2019-07-31	30-day Notice
S188
S187
S186	2019-06-06	30-day Notice
S185
S184	2019-01-30	30-day Notice
S183
S182	2018-11-01	Normal 180 Day Track
S181	2018-08-13	30-day Notice
S180	2018-06-11	Special (immediate Track)
S179	2018-04-27	Special (immediate Track)
S178	2018-04-13	30-day Notice
S177	2018-02-15	30-day Notice
S176	2018-02-02	30-day Notice
S175	2018-01-02	30-day Notice
S174	2018-01-02	30-day Notice
S173	2017-11-13	Normal 180 Day Track
S172
S171	2017-09-28	30-day Notice
S170	2017-08-25	135 Review Track For 30-day Notice
S169	2017-08-07	30-day Notice
S168	2017-07-26	30-day Notice
S167	2017-07-17	30-day Notice
S166	2017-06-21	Real-time Process
S165	2017-06-07	30-day Notice
S164	2017-05-23	Normal 180 Day Track
S163	2017-05-16	30-day Notice
S162	2017-04-24	30-day Notice
S161	2017-04-18	Real-time Process
S160	2017-04-10	30-day Notice
S159	2017-03-23	30-day Notice
S158	2017-02-27	30-day Notice
S157	2017-02-09	Special (immediate Track)
S156	2017-02-07	30-day Notice
S155	2016-12-21	30-day Notice
S154	2016-11-23	30-day Notice
S153	2016-11-23	30-day Notice
S152
S151	2016-10-12	Normal 180 Day Track
S150	2016-09-22	30-day Notice
S149	2016-07-25	30-day Notice
S148	2016-06-23	30-day Notice
S147	2016-06-15	135 Review Track For 30-day Notice
S146	2016-05-27	30-day Notice
S145	2016-02-24	30-day Notice
S144	2016-02-24	Normal 180 Day Track
S143	2016-02-08	Normal 180 Day Track
S142	2016-01-06	30-day Notice
S141	2016-01-05	30-day Notice
S140	2015-12-23	Normal 180 Day Track
S139	2015-12-17	30-day Notice
S138	2015-12-04	30-day Notice
S137	2015-11-23	Normal 180 Day Track
S136	2015-10-23	30-day Notice
S135	2015-10-13	30-day Notice
S134	2015-09-14	30-day Notice
S133	2015-07-31	Normal 180 Day Track
S132	2015-07-23	Normal 180 Day Track No User Fee
S131	2015-05-18	135 Review Track For 30-day Notice
S130	2015-05-07	135 Review Track For 30-day Notice
S129	2015-03-23	Real-time Process
S128	2015-02-13	30-day Notice
S127	2014-12-24	30-day Notice
S126	2014-11-14	Normal 180 Day Track
S125	2014-11-12	30-day Notice
S124	2014-11-12	30-day Notice
S123	2014-10-02	Normal 180 Day Track
S122	2014-07-23	30-day Notice
S121	2014-06-09	Real-time Process
S120	2014-05-16	30-day Notice
S119	2014-04-17	30-day Notice
S118	2014-03-28	30-day Notice
S117
S116	2014-01-27	Normal 180 Day Track
S115	2014-01-22	30-day Notice
S114	2014-01-15	Real-time Process
S113	2013-10-22	135 Review Track For 30-day Notice
S112	2013-09-26	Real-time Process
S111	2013-07-29	30-day Notice
S110	2013-06-28	Normal 180 Day Track
S109	2013-04-10	30-day Notice
S108	2013-04-04	135 Review Track For 30-day Notice
S107	2013-03-27	135 Review Track For 30-day Notice
S106	2013-02-25	30-day Notice
S105	2013-02-07	135 Review Track For 30-day Notice
S104	2013-01-16	Normal 180 Day Track
S103	2012-12-24	Real-time Process
S102
S101	2012-11-15	135 Review Track For 30-day Notice
S100	2012-11-15	135 Review Track For 30-day Notice
S099
S098	2012-10-23	30-day Notice
S097	2012-09-11	Real-time Process
S096	2012-08-27	Normal 180 Day Track
S095	2012-08-06	30-day Notice
S094	2012-08-02	Normal 180 Day Track
S093	2012-07-31	Real-time Process
S092	2012-07-27	30-day Notice
S091	2012-07-13	Normal 180 Day Track
S090
S089	2011-12-30	Real-time Process
S088	2011-10-26	Real-time Process
S087	2011-09-22	Real-time Process
S086	2011-08-29	135 Review Track For 30-day Notice
S085	2011-08-05	Real-time Process
S084
S083
S082	2011-06-29	135 Review Track For 30-day Notice
S081
S080	2011-06-27	30-day Notice
S079
S078	2011-06-24	30-day Notice
S077	2011-05-19	30-day Notice
S076	2011-05-19	30-day Notice
S075	2011-05-19	135 Review Track For 30-day Notice
S074	2011-05-19	135 Review Track For 30-day Notice
S073	2011-05-19	135 Review Track For 30-day Notice
S072
S071	2011-05-16	30-day Notice
S070	2011-05-16	135 Review Track For 30-day Notice
S069	2011-04-06	Real-time Process
S068	2011-03-10	Special (immediate Track)
S067	2011-02-03	30-day Notice
S066
S065	2010-11-19	30-day Notice
S064	2010-10-01	Normal 180 Day Track
S063	2010-09-27	Real-time Process
S062	2009-12-23	Real-time Process
S061
S060	2009-12-09	135 Review Track For 30-day Notice
S059	2009-11-09	135 Review Track For 30-day Notice
S058	2009-11-02	30-day Notice
S057	2009-10-26	135 Review Track For 30-day Notice
S056
S055	2009-10-13	Special (immediate Track)
S054	2009-10-05	135 Review Track For 30-day Notice
S053	2009-09-25	Normal 180 Day Track
S052	2009-07-22	135 Review Track For 30-day Notice
S051	2009-06-11	30-day Notice
S050	2009-05-20	Real-time Process
S049	2008-12-19	Normal 180 Day Track
S048	2008-11-25	Normal 180 Day Track
S047	2008-08-08	30-day Notice
S046	2008-07-25	30-day Notice
S045	2007-10-09	Real-time Process
S044	2007-08-24	30-day Notice
S043	2007-08-24	30-day Notice
S042	2007-08-24	30-day Notice
S041	2007-08-24	30-day Notice
S040
S039	2006-09-05	30-day Notice
S038	2006-04-21	Real-time Process
S037	2006-04-13	Real-time Process
S036	2006-01-24	30-day Notice
S035	2005-12-20	Real-time Process
S034	2005-09-23	Real-time Process
S033
S032
S031	2005-03-15	Real-time Process
S030	2005-03-09	30-day Notice
S029	2004-09-17	Normal 180 Day Track
S028	2004-07-01	Normal 180 Day Track
S027	2003-10-06	Real-time Process
S026	2003-09-04	Real-time Process
S025	2003-08-13	Normal 180 Day Track No User Fee
S024	2002-12-06	Normal 180 Day Track
S023	2002-10-31	Normal 180 Day Track
S022	2002-08-28	Special (immediate Track)
S021	2002-07-16	Normal 180 Day Track
S020	2002-06-13	Real-time Process
S019	2001-10-23	Normal 180 Day Track
S018	2001-07-23	Normal 180 Day Track
S017	2001-06-22	Normal 180 Day Track
S016	2001-04-19	Normal 180 Day Track
S015	2001-03-19	Normal 180 Day Track
S014	2001-01-16	Real-time Process
S013	2000-12-29	Normal 180 Day Track
S012	2000-11-29	Normal 180 Day Track
S011	2000-07-21	Normal 180 Day Track
S010	2000-02-23	Normal 180 Day Track
S009	1999-12-17	Real-time Process
S008	1999-09-20	Normal 180 Day Track
S007	1999-08-13	Real-time Process
S006	1999-04-15	30-day Notice
S005	1999-03-26	Real-time Process
S004	1999-01-08	Normal 180 Day Track
S003	1998-08-17	Normal 180 Day Track
S002	1998-07-20	Real-time Process
S001	1998-07-16	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
09321502014540	P970051	000
09321502027601	P970051	000
09321502027649	P970051	000
09321502027656	P970051	000
09321502033305	P970051	000
09321502007184	P970051	000
09321502008402	P970051	000
09321502030427	P970051	000
09321502011624	P970051	000
09321502011556	P970051	000
09321502011174	P970051	000
09321502027670	P970051	000
09321502025676	P970051	000
09321502029483	P970051	000
09321502033312	P970051	000
09321502029612	P970051	000
09321502029353	P970051	000
09321502032926	P970051	000
09321502032933	P970051	000
09321502032940	P970051	000
09321502032957	P970051	000
09321502032964	P970051	000
09321502002448	P970051	000
09321502008617	P970051	000
09321502029384	P970051	000
09321502032971	P970051	000
09321502009126	P970051	000
09321502002318	P970051	010
09321502003216	P970051	015
09321502027809	P970051	016
09321502029346	P970051	016
09321502006637	P970051	016
09321502033770	P970051	016
09321502006422	P970051	019
09321502012058	P970051	019
09321502012041	P970051	019
09321502012034	P970051	019
09321502012027	P970051	019
09321502029575	P970051	019
09321502011334	P970051	019
09321502029582	P970051	019
09321502009218	P970051	025
09321502009584	P970051	025
09321502014564	P970051	025
09321502002493	P970051	025
09321502013628	P970051	028
09321502013482	P970051	028
09321502028028	P970051	028
09321502028011	P970051	028
09321502028035	P970051	028
09321502028103	P970051	028
09321502013475	P970051	028
09321502013352	P970051	028
09321502013420	P970051	028
09321502027991	P970051	028
09321502028004	P970051	028
09321502013635	P970051	028
09321502029032	P970051	028
09321502002349	P970051	028
09321502007320	P970051	028
09321502027878	P970051	028
09321502008891	P970051	028
09321502016537	P970051	028
09321502027885	P970051	028
09321502027892	P970051	028
09321502027960	P970051	028
09321502027977	P970051	028
09321502027984	P970051	028
09321502016483	P970051	028
09321502013642	P970051	028
09321502028882	P970051	028
09321502015325	P970051	028
09321502013109	P970051	028
09321502013093	P970051	028
09321502011594	P970051	028
09321502011587	P970051	028
09321502011549	P970051	028
09321502011532	P970051	028
09321502011525	P970051	028
09321502010382	P970051	028
09321502010368	P970051	028
09321502013178	P970051	028
09321502013222	P970051	028
09321502013321	P970051	028
09321502015301	P970051	028
09321502014731	P970051	028
09321502013765	P970051	028
09321502013758	P970051	028
09321502013741	P970051	028
09321502013734	P970051	028
09321502013727	P970051	028
09321502013710	P970051	028
09321502013338	P970051	028
09321502010344	P970051	028
09321502010269	P970051	028
09321502010245	P970051	028
09321502010306	P970051	028
09321502013239	P970051	028
09321502029704	P970051	028
09321502029698	P970051	028
09321502029681	P970051	028
09321502029674	P970051	028
09321502029667	P970051	028
09321502029650	P970051	028
09321502029414	P970051	028
09321502013451	P970051	028
09321502029247	P970051	028
09321502029254	P970051	028
09321502010221	P970051	028
09321502010146	P970051	028
09321502010122	P970051	028
09321502010085	P970051	028
09321502010047	P970051	028
09321502009577	P970051	028
09321502029285	P970051	028
09321502029278	P970051	028
09321502029261	P970051	028
09321502029391	P970051	028
09321502008600	P970051	028
09321502028127	P970051	028
09321502013246	P970051	028
09321502012201	P970051	028
09321502028929	P970051	028
09321502011921	P970051	028
09321502015295	P970051	028
09321502028936	P970051	028
09321502028943	P970051	028
09321502008587	P970051	028
09321502029094	P970051	028
09321502018913	P970051	028
09321502028967	P970051	028
09321502028110	P970051	028
09321502008921	P970051	028
09321502013499	P970051	028
09321502008617	P970051	028
09321502008839	P970051	028
09321502027953	P970051	028
09321502028042	P970051	028
09321502028059	P970051	028
09321502028066	P970051	028
09321502028080	P970051	028
09321502028097	P970051	028
09321502013598	P970051	028
09321502028950	P970051	028
09321502013581	P970051	028
09321502013574	P970051	028
09321502012195	P970051	028
09321502012188	P970051	028
09321502010207	P970051	028
09321502029155	P970051	028
09321502029131	P970051	028
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09321502029100	P970051	028
09321502029087	P970051	028
09321502029070	P970051	028
09321502029063	P970051	028
09321502029056	P970051	028
09321502029438	P970051	028
09321502028981	P970051	028
09321502028998	P970051	028
09321502029001	P970051	028
09321502029162	P970051	028
09321502029421	P970051	028
09321502029179	P970051	028
09321502010023	P970051	028
09321502009560	P970051	028
09321502009553	P970051	028
09321502009546	P970051	028
09321502009539	P970051	028
09321502028974	P970051	028
09321502009522	P970051	028
09321502009515	P970051	028
09321502002332	P970051	028
09321502029230	P970051	028
09321502029223	P970051	028
09321502029186	P970051	028
09321502029049	P970051	028
09321502027946	P970051	028
09321502013260	P970051	028
09321502012324	P970051	028
09321502012256	P970051	028
09321502012447	P970051	028
09321502012317	P970051	028
09321502012300	P970051	028
09321502012294	P970051	028
09321502012287	P970051	028
09321502012270	P970051	028
09321502012263	P970051	028
09321502012331	P970051	028
09321502012409	P970051	028
09321502013154	P970051	028
09321502013147	P970051	028
09321502013130	P970051	028
09321502012539	P970051	028
09321502013314	P970051	028
09321502012522	P970051	028
09321502012492	P970051	028
09321502012485	P970051	028
09321502012454	P970051	028
09321502012249	P970051	028
09321502012232	P970051	028
09321502027939	P970051	028
09321502027823	P970051	028
09321502027830	P970051	028
09321502027847	P970051	028
09321502013253	P970051	028
09321502027922	P970051	028
09321502012225	P970051	028
09321502008594	P970051	028
09321502027854	P970051	028
09321502012218	P970051	028
09321502027861	P970051	028
09321502027908	P970051	028
09321502027915	P970051	028
09321502027816	P970051	028
09321502019439	P970051	048
09321502006842	P970051	048
09321502002790	P970051	048
09321502013369	P970051	048
09321502014557	P970051	048
09321502018197	P970051	049
09321502018029	P970051	049
09321502019897	P970051	049
09321502019880	P970051	049
09321502018036	P970051	049
09321502019842	P970051	049
09321502019835	P970051	049
09321502019828	P970051	049
09321502019811	P970051	049
09321502018067	P970051	049
09321502017640	P970051	049
09321502018920	P970051	049
09321502018333	P970051	049
09321502018043	P970051	049
09321502018050	P970051	049
09321502017879	P970051	049
09321502017862	P970051	049
09321502017848	P970051	049
09321502017169	P970051	049
09321502017176	P970051	049
09321502017534	P970051	049
09321502017541	P970051	049
09321502017558	P970051	049
09321502017602	P970051	049
09321502019903	P970051	049
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09321502017152	P970051	049
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09321502017091	P970051	049
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09321502017138	P970051	049
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09321502017107	P970051	049
09321502020107	P970051	049
09321502018319	P970051	049
09321502018302	P970051	049
09321502018296	P970051	049
09321502018272	P970051	049
09321502018265	P970051	049
09321502018258	P970051	049
09321502018234	P970051	049
09321502018227	P970051	049
09321502018326	P970051	049
09321502018357	P970051	049
09321502019453	P970051	049
09321502020091	P970051	049
09321502020084	P970051	049
09321502020077	P970051	049
09321502020060	P970051	049
09321502020053	P970051	049
09321502020046	P970051	049
09321502019941	P970051	049
09321502019859	P970051	049
09321502018210	P970051	049
09321502018203	P970051	049
09321502018173	P970051	049
09321502016971	P970051	049
09321502016964	P970051	049
09321502016957	P970051	049
09321502016940	P970051	049
09321502016933	P970051	049
09321502016926	P970051	049
09321502016919	P970051	049
09321502016902	P970051	049
09321502017268	P970051	049
09321502017367	P970051	049
09321502017398	P970051	049
09321502018166	P970051	049
09321502018159	P970051	049
09321502018111	P970051	049
09321502018074	P970051	049
09321502017893	P970051	049
09321502017626	P970051	049
09321502017596	P970051	049
09321502017411	P970051	049
09321502016896	P970051	049
09321502019910	P970051	049
09321502020374	P970051	049
09321502022613	P970051	049
09321502022620	P970051	049
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09321502020367	P970051	049
09321502020022	P970051	049
09321502020015	P970051	049
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09321502019965	P970051	049
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09321502020008	P970051	049
09321502029728	P970051	049
09321502029711	P970051	049
09321502025614	P970051	049
09321502025553	P970051	049
09321502025539	P970051	049
09321502021050	P970051	049
09321502020244	P970051	049
09321502020152	P970051	049
09321502020145	P970051	049
09321502020138	P970051	049
09321502020121	P970051	049
09321502025560	P970051	049
09321502025577	P970051	049
09321502025584	P970051	049
09321502029544	P970051	049
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