P970038S018

None

FDA Premarket Approval P970038 S018

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: P970038S018
• Classification Name: None
• PMA: P970038
• Supplement: S018

Supplemental Filings

Supplement Number	Date	Supplement Type
P970038		Original Filing
S045	2021-04-19	Real-time Process
S044	2020-09-30	Real-time Process
S043	2020-07-22	Real-time Process
S042	2020-06-23	Real-time Process
S041	2019-12-18	Real-time Process
S040	2019-05-13	Real-time Process
S039	2019-05-02	Real-time Process
S038
S037	2018-09-25	Real-time Process
S036	2017-09-28	30-day Notice
S035
S034	2017-06-09	30-day Notice
S033	2017-03-22	Real-time Process
S032	2017-01-17	30-day Notice
S031	2015-05-07	Real-time Process
S030	2015-01-27	135 Review Track For 30-day Notice
S029	2014-11-04	135 Review Track For 30-day Notice
S028	2014-08-25	Real-time Process
S027	2014-08-25	135 Review Track For 30-day Notice
S026	2013-12-17	Real-time Process
S025	2013-09-26	Special (immediate Track)
S024	2013-06-13	Special (immediate Track)
S023	2013-04-12	Special (immediate Track)
S022	2013-03-29	Real-time Process
S021	2013-01-23	Real-time Process
S020	2013-01-03	30-day Notice
S019
S018
S017	2012-10-25	Special (immediate Track)
S016	2012-03-15	Special (immediate Track)
S015	2011-12-23	Real-time Process
S014	2011-01-12	Special (immediate Track)
S013	2011-01-10	Special (immediate Track)
S012	2008-05-27	Normal 180 Day Track
S011	2007-12-19	Real-time Process
S010	2007-05-14	30-day Notice
S009	2007-05-16	Normal 180 Day Track
S008	2006-04-10	Real-time Process
S007	2002-12-20	Real-time Process
S006	2002-10-07	Real-time Process
S005	2002-08-19	Normal 180 Day Track
S004	1999-08-27	Normal 180 Day Track
S003	1999-05-14	Normal 180 Day Track
S002	1999-04-27	Normal 180 Day Track
S001	1998-07-23	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
H628372101	P970038	004