P060037S025

None

FDA Premarket Approval P060037 S025

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: P060037S025
• Classification Name: None
• PMA: P060037
• Supplement: S025

Supplemental Filings

Supplement Number	Date	Supplement Type
P060037		Original Filing
S082	2022-09-30	30-day Notice
S081
S080	2022-07-25	Special (immediate Track)
S079	2022-05-09	30-day Notice
S078	2022-03-07	30-day Notice
S077	2022-01-31	30-day Notice
S076	2021-12-10	30-day Notice
S075	2021-09-30	30-day Notice
S074	2021-08-10	30-day Notice
S073
S072	2021-06-21	30-day Notice
S071	2021-06-10	30-day Notice
S070	2020-11-25	30-day Notice
S069	2020-09-28	Real-time Process
S068	2020-09-21	30-day Notice
S067	2020-09-17	30-day Notice
S066	2020-07-28	30-day Notice
S065	2020-06-16	30-day Notice
S064	2020-05-07	30-day Notice
S063
S062	2019-09-26	30-day Notice
S061	2019-07-11	30-day Notice
S060	2019-06-03	30-day Notice
S059
S058
S057	2018-11-07	30-day Notice
S056	2018-04-23	30-day Notice
S055	2018-02-27	30-day Notice
S054	2018-02-20	30-day Notice
S053	2017-10-19	30-day Notice
S052	2017-09-29	30-day Notice
S051	2017-09-07	30-day Notice
S050	2017-08-31	30-day Notice
S049	2017-06-07	30-day Notice
S048	2016-11-23	30-day Notice
S047	2016-09-08	Normal 180 Day Track No User Fee
S046	2016-08-08	30-day Notice
S045	2016-05-03	30-day Notice
S044	2016-03-31	30-day Notice
S043	2015-12-17	Special (immediate Track)
S042	2015-10-30	30-day Notice
S041	2015-10-16	30-day Notice
S040	2015-09-30	30-day Notice
S039	2015-08-12	30-day Notice
S038	2015-06-29	135 Review Track For 30-day Notice
S037	2015-06-26	30-day Notice
S036	2015-06-22	Special (immediate Track)
S035	2015-03-17	30-day Notice
S034	2015-02-24	30-day Notice
S033	2014-12-04	30-day Notice
S032	2014-09-30	135 Review Track For 30-day Notice
S031	2014-08-28	135 Review Track For 30-day Notice
S030	2014-02-18	Normal 180 Day Track No User Fee
S029	2014-01-22	30-day Notice
S028	2013-09-30	135 Review Track For 30-day Notice
S027	2013-09-23	135 Review Track For 30-day Notice
S026	2013-08-08	Normal 180 Day Track No User Fee
S025
S024	2013-07-15	135 Review Track For 30-day Notice
S023	2013-07-01	30-day Notice
S022	2013-05-23	30-day Notice
S021	2013-03-25	135 Review Track For 30-day Notice
S020	2012-09-27	135 Review Track For 30-day Notice
S019	2012-08-21	135 Review Track For 30-day Notice
S018	2012-07-13	30-day Notice
S017	2012-04-06	135 Review Track For 30-day Notice
S016	2012-01-12	30-day Notice
S015	2011-11-23	30-day Notice
S014	2011-07-05	135 Review Track For 30-day Notice
S013	2010-05-12	Special (immediate Track)
S012	2010-04-06	Normal 180 Day Track No User Fee
S011	2009-06-10	30-day Notice
S010	2009-05-22	Special (immediate Track)
S009	2009-04-24	Normal 180 Day Track
S008	2009-04-21	30-day Notice
S007	2008-11-25	Real-time Process
S006	2008-10-10	135 Review Track For 30-day Notice
S005	2008-09-29	Normal 180 Day Track
S004	2008-09-02	Normal 180 Day Track No User Fee
S003	2008-06-06	135 Review Track For 30-day Notice
S002
S001	2008-01-29	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00889024000537	P060037	000
00889024000346	P060037	000
00889024000421	P060037	000
00889024000001	P060037	000
00889024000025	P060037	000
00889024000100	P060037	000
00889024000186	P060037	000
00889024000056	P060037	000
00889024000063	P060037	000
00889024000070	P060037	000
00889024000087	P060037	000
00889024000094	P060037	000
00889024000124	P060037	000
00889024000131	P060037	000
00889024000148	P060037	000
00889024000155	P060037	000
00889024000261	P060037	000
00889024000704	P060037	000
00889024000698	P060037	000
00889024000544	P060037	000
00889024000551	P060037	000
00889024000568	P060037	000
00889024000575	P060037	000
00889024000582	P060037	000
00889024000599	P060037	000
00889024000605	P060037	000
00889024000612	P060037	000
00889024000629	P060037	000
00889024000636	P060037	000
00889024000643	P060037	000
00889024000650	P060037	000
00889024000667	P060037	000
00889024000674	P060037	000
00889024000681	P060037	000
00889024000162	P060037	000
00889024000179	P060037	000
00889024000209	P060037	000
00889024000469	P060037	000
00889024000476	P060037	000
00889024000483	P060037	000
00889024000490	P060037	000
00889024000322	P060037	000
00889024000018	P060037	000
00889024000032	P060037	000
00889024000117	P060037	000
00889024000193	P060037	000
00889024000278	P060037	000
00889024000353	P060037	000
00889024000438	P060037	000
00889024000513	P060037	000
00889024000933	P060037	000
00889024000940	P060037	000
00889024000452	P060037	000
00889024000445	P060037	000
00889024000414	P060037	000
00889024000216	P060037	000
00889024000223	P060037	000
00889024000230	P060037	000
00889024000247	P060037	000
00889024000254	P060037	000
00889024000285	P060037	000
00889024000292	P060037	000
00889024000308	P060037	000
00889024000315	P060037	000
00889024000339	P060037	000
00889024000360	P060037	000
00889024000377	P060037	000
00889024000384	P060037	000
00889024000391	P060037	000
00889024000407	P060037	000
00889024000957	P060037	000
00889024665118	P060037	000
00889024665309	P060037	000
00889024665316	P060037	000
00889024665323	P060037	000
00889024665330	P060037	000
00889024665347	P060037	000
00889024665354	P060037	000
00889024665361	P060037	000
00889024665378	P060037	000
00889024665385	P060037	000
00889024000049	P060037	000
00889024000520	P060037	000
00889024633995	P060037	000
00889024634008	P060037	000
00889024634015	P060037	000
00889024634022	P060037	000
00889024665293	P060037	000
00889024665286	P060037	000
00889024665279	P060037	000
00889024665125	P060037	000
00889024665132	P060037	000
00889024665149	P060037	000
00889024665156	P060037	000
00889024665163	P060037	000
00889024665170	P060037	000
00889024665187	P060037	000
00889024665194	P060037	000
00889024665200	P060037	000
00889024665217	P060037	000
00889024665224	P060037	000
00889024665231	P060037	000
00889024665248	P060037	000
00889024665255	P060037	000
00889024665262	P060037	000
00889024634039	P060037	000
00889024634046	P060037	000
00889024634053	P060037	000
00889024634244	P060037	000
00889024634251	P060037	000
00889024634268	P060037	000
00889024000711	P060037	000
00889024000728	P060037	000
00889024000735	P060037	000
00889024000742	P060037	000
00889024000759	P060037	000
00889024000766	P060037	000
00889024000773	P060037	000
00889024000780	P060037	000
00889024000797	P060037	000
00889024000803	P060037	000
00889024000810	P060037	000
00889024000827	P060037	000
00889024634237	P060037	000
00889024634220	P060037	000
00889024634213	P060037	000
00889024634060	P060037	000
00889024634077	P060037	000
00889024634084	P060037	000
00889024634091	P060037	000
00889024634107	P060037	000
00889024634114	P060037	000
00889024634121	P060037	000
00889024634138	P060037	000
00889024634145	P060037	000
00889024634152	P060037	000
00889024634169	P060037	000
00889024634176	P060037	000
00889024634183	P060037	000
00889024634190	P060037	000
00889024634206	P060037	000
00889024000506	P060037	000
08890240001118	P060037	000
08890240001002	P060037	000
08890240000999	P060037	000
08890240000982	P060037	000
08890240000975	P060037	000
08890240000968	P060037	000
08890240000951	P060037	000
08890240000944	P060037	000
08890240000937	P060037	000
08890240001019	P060037	000
08890240001026	P060037	000
08890240001101	P060037	000
08890240001095	P060037	000
08890240001088	P060037	000
08890240001071	P060037	000
08890240001064	P060037	000
08890240001057	P060037	000
08890240001040	P060037	000
08890240001033	P060037	000
08890240000821	P060037	000
08890240000517	P060037	000
08890240000500	P060037	000
08890240000036	P060037	000
08890240000029	P060037	000
08890240000012	P060037	000
08890240000005	P060037	000
00889024001565	P060037	000
00889024001558	P060037	000
00889024001541	P060037	000
00889024001534	P060037	000
08890240000104	P060037	000
08890240000111	P060037	000
08890240000432	P060037	000
08890240000425	P060037	000
08890240000357	P060037	000
08890240000340	P060037	000
08890240000272	P060037	000
08890240000265	P060037	000
08890240000197	P060037	000
08890240000180	P060037	000
00889024001527	P060037	000
08890240001569	P060037	000
08890240001453	P060037	000
08890240001446	P060037	000
08890240001439	P060037	000
08890240001422	P060037	000
08890240001415	P060037	000
08890240001408	P060037	000
08890240001392	P060037	000
08890240001385	P060037	000
08890240001460	P060037	000
08890240001477	P060037	000
08890240001552	P060037	000
08890240001545	P060037	000
08890240001538	P060037	000
08890240001521	P060037	000
08890240001514	P060037	000
08890240001507	P060037	000
08890240001491	P060037	000
08890240001484	P060037	000
08890240001378	P060037	000
08890240001347	P060037	000
08890240001330	P060037	000
08890240001200	P060037	000
08890240001194	P060037	000
08890240001187	P060037	000
08890240001170	P060037	000
08890240001163	P060037	000
08890240001156	P060037	000
08890240001149	P060037	000
08890240001132	P060037	000
08890240001217	P060037	000
08890240001224	P060037	000
08890240001309	P060037	000
08890240001293	P060037	000
08890240001286	P060037	000
08890240001279	P060037	000
08890240001262	P060037	000
08890240001255	P060037	000
08890240001248	P060037	000
08890240001231	P060037	000
08890240001125	P060037	000
00889024001510	P060037	000
00889024000971	P060037	000
00889024001121	P060037	000
00889024001138	P060037	000
00889024001145	P060037	000
00889024001152	P060037	000
00889024001169	P060037	000
00889024001176	P060037	000
00889024001183	P060037	000
00889024001190	P060037	000
00889024001206	P060037	000
00889024001213	P060037	000
00889024001220	P060037	000
00889024001237	P060037	000
00889024001244	P060037	000
00889024001114	P060037	000
00889024001107	P060037	000
00889024000988	P060037	000
00889024000995	P060037	000
00889024001008	P060037	000
00889024001015	P060037	000
00889024001022	P060037	000
00889024001039	P060037	000
00889024001046	P060037	000
00889024001053	P060037	000
00889024001060	P060037	000
00889024001077	P060037	000
00889024001091	P060037	000
00889024000964	P060037	000
00889024001084	P060037	000
00889024001251	P060037	000
00889024001336	P060037	000
00889024001374	P060037	000
00889024001503	P060037	000
00889024001381	P060037	000
00889024001497	P060037	000
00889024001480	P060037	000
00889024001473	P060037	000
00889024001466	P060037	000
00889024001398	P060037	000
00889024001442	P060037	000
00889024001435	P060037	000
00889024001428	P060037	000
00889024001459	P060037	000
00889024001411	P060037	000
00889024001343	P060037	000
00889024001404	P060037	000
00889024001268	P060037	000
00889024001275	P060037	000
00889024001282	P060037	000
00889024001299	P060037	000
00889024001305	P060037	000
08890240000890	P060037	005
08890240000883	P060037	005
08890240000876	P060037	005
08890240000869	P060037	005
08890240000906	P060037	005
08890240000838	P060037	005
08890240000845	P060037	005
08890240000852	P060037	005
00889024000049	P060037	005
00889024000810	P060037	009
00889024000735	P060037	009
00889024000742	P060037	009
00889024000759	P060037	009
00889024000766	P060037	009
00889024000704	P060037	009
00889024000797	P060037	009
00889024000803	P060037	009
00889024000780	P060037	009
00889024000728	P060037	009
00889024000568	P060037	009
00889024000599	P060037	009
00889024000582	P060037	009
00889024000575	P060037	009
00889024000551	P060037	009
00889024000544	P060037	009
00889024000537	P060037	009
00889024000520	P060037	009
00889024000711	P060037	009
00889024000605	P060037	009
00889024000612	P060037	009
00889024000698	P060037	009
00889024000681	P060037	009
00889024000674	P060037	009
00889024000667	P060037	009
00889024000650	P060037	009
00889024000643	P060037	009
00889024000636	P060037	009
00889024000629	P060037	009
00889024000773	P060037	009