N16837S013

None

FDA Premarket Approval N16837 S013

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: N16837S013
• Classification Name: None
• PMA: N16837
• Supplement: S013

Supplemental Filings

Supplement Number	Date	Supplement Type
N16837		Original Filing
S029	2022-12-30	30-day Notice
S028	2022-09-16	30-day Notice
S027
S026	2020-04-07	30-day Notice
S025	2018-06-15	30-day Notice
S024	2017-12-29	30-day Notice
S023	2017-12-19	30-day Notice
S022	2017-08-16	30-day Notice
S021	2015-09-11	Real-time Process
S020	2015-04-01	Special (immediate Track)
S019	2015-03-06	Real-time Process
S018	2014-09-04	30-day Notice
S017	2014-07-30	30-day Notice
S016
S015	2014-07-07	Special (immediate Track)
S014	2014-06-11	Real-time Process
S013
S012	2014-02-27	30-day Notice
S011	2013-04-26	Normal 180 Day Track No User Fee
S010	2012-09-24	135 Review Track For 30-day Notice
S009	2011-12-28	135 Review Track For 30-day Notice
S008	2011-09-20	135 Review Track For 30-day Notice
S007	2009-06-22	30-day Notice
S006	2008-08-11	135 Review Track For 30-day Notice
S005	2006-11-03	Real-time Process
S004	2006-02-01	30-day Notice
S003	1999-07-29	Normal 180 Day Track
S002
S001	1979-06-29

NIH GUDID Devices

Device ID	PMA	Supp
00316837000367	N16837	000
00316837000190	N16837	015
00316837000206	N16837	015
00316837000213	N16837	015
00316837000220	N16837	015
00316837000237	N16837	015
00316837000244	N16837	015
00316837000251	N16837	015
00316837000268	N16837	015
00316837000275	N16837	015
00316837000282	N16837	015
00316837000299	N16837	015
00316837000305	N16837	015
00316837000312	N16837	015
00316837000329	N16837	015
00316837000336	N16837	015
00316837000343	N16837	015
00316837000350	N16837	015