P090018S015

None

FDA Premarket Approval P090018 S015

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: P090018S015
• Classification Name: None
• PMA: P090018
• Supplement: S015

Supplemental Filings

Supplement Number	Date	Supplement Type
P090018		Original Filing
S041	2022-03-23	Normal 180 Day Track No User Fee
S040
S039	2019-09-05	Normal 180 Day Track No User Fee
S038	2019-08-28	30-day Notice
S037	2018-05-02	Real-time Process
S036	2017-05-10	30-day Notice
S035	2017-03-17	30-day Notice
S034	2017-03-13	135 Review Track For 30-day Notice
S033	2016-10-28	Real-time Process
S032	2016-04-21	Normal 180 Day Track No User Fee
S031	2016-02-04	Normal 180 Day Track No User Fee
S030	2015-09-23	Normal 180 Day Track No User Fee
S029	2015-03-23	Real-time Process
S028	2014-12-31	30-day Notice
S027	2014-06-12	Real-time Process
S026	2014-05-23	Real-time Process
S025	2014-03-12	30-day Notice
S024	2013-08-08	Real-time Process
S023	2013-08-01	30-day Notice
S022
S021	2013-05-29	30-day Notice
S020	2013-05-01	Special (immediate Track)
S019	2013-04-19	Special (immediate Track)
S018	2012-08-29	30-day Notice
S017	2011-11-14	30-day Notice
S016	2011-11-02	Normal 180 Day Track
S015
S014	2011-10-24	Real-time Process
S013	2011-08-26	Real-time Process
S012	2011-08-16	30-day Notice
S011	2011-06-14	135 Review Track For 30-day Notice
S010	2011-05-20	Normal 180 Day Track No User Fee
S009	2011-05-10	Real-time Process
S008	2010-10-27	30-day Notice
S007	2010-08-18	30-day Notice
S006
S005	2010-08-09	30-day Notice
S004	2010-07-27	135 Review Track For 30-day Notice
S003	2010-06-17	Normal 180 Day Track No User Fee
S002	2010-06-17	Normal 180 Day Track No User Fee
S001	2010-04-07	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
20812282020225	P090018	000
00812282020368	P090018	000
00812282020320	P090018	000
00812282020313	P090018	000
00812282020276	P090018	000
00812282020252	P090018	000
00812282020207	P090018	000
00812282020191	P090018	000
00812282020184	P090018	000
00812282020177	P090018	000
00812282020160	P090018	000
00812282020146	P090018	000
00812282020139	P090018	000
00812282020122	P090018	000
00812282020078	P090018	000
00812282020269	P090018	000
00812282020610	P090018	000
00812282020573	P090018	000
00812282020559	P090018	000
00812282020542	P090018	000
00812282020535	P090018	000
00812282020528	P090018	000
00812282020474	P090018	000
00812282020467	P090018	000
00812282020450	P090018	000
00812282020443	P090018	000
00812282020436	P090018	000
00812282020016	P090018	001
00812282020047	P090018	001
00812282020351	P090018	005
00812282020337	P090018	005
00812282020344	P090018	005
00812282020481	P090018	009
00812282020399	P090018	014
00812282020290	P090018	014
00812282020306	P090018	014
00812282020382	P090018	014
00812282020405	P090018	014
00812282020412	P090018	014
00812282020030	P090018	016
00812282020009	P090018	016
00812282020023	P090018	017
00812282020214	P090018	017
00812282020054	P090018	017
00812282020603	P090018	023
00812282020283	P090018	023
00812282020429	P090018	024
00812282020504	P090018	026
00812282020498	P090018	026