P890064S010

None

FDA Premarket Approval P890064 S010

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: P890064S010
• Classification Name: None
• PMA: P890064
• Supplement: S010

Supplemental Filings

Supplement Number	Date	Supplement Type
P890064		Original Filing
S041	2020-05-20	30-day Notice
S040	2018-02-28	30-day Notice
S039	2018-02-16	30-day Notice
S038	2018-02-16	30-day Notice
S037	2018-01-26	30-day Notice
S036	2018-01-11	30-day Notice
S035	2017-11-30	30-day Notice
S034	2017-06-29	30-day Notice
S033	2016-02-19	Real-time Process
S032	2015-04-28	Normal 180 Day Track No User Fee
S031	2014-09-23	Real-time Process
S030	2014-03-21	Real-time Process
S029	2013-08-15	Normal 180 Day Track No User Fee
S028
S027	2011-07-28	Normal 180 Day Track No User Fee
S026	2011-02-28	Real-time Process
S025	2011-02-28	30-day Notice
S024	2010-04-15	30-day Notice
S023	2010-04-15	30-day Notice
S022	2010-04-15	30-day Notice
S021	2010-02-03	Normal 180 Day Track No User Fee
S020	2008-01-29	Normal 180 Day Track No User Fee
S019
S018	2006-03-24	Real-time Process
S017	2004-11-19	Special (immediate Track)
S016
S015	2004-05-28	Real-time Process
S014	2003-11-05	Normal 180 Day Track
S013	2003-10-01	Real-time Process
S012	2003-05-20	Special (immediate Track)
S011
S010
S009	2001-10-01	Panel Track
S008	2000-08-25	Normal 180 Day Track
S007	2000-02-07	Normal 180 Day Track
S006	1997-09-30	Normal 180 Day Track
S005	1996-11-01	Normal 180 Day Track
S004	1996-05-03	Normal 180 Day Track
S003	1993-09-27	Normal 180 Day Track
S002	1992-12-09	Normal 180 Day Track
S001	1991-10-18	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
04053228010777	P890064	000
04053228002031	P890064	000
04053228002024	P890064	000
04053228002000	P890064	000
14053228002014	P890064	000