P130016S046

None

FDA Premarket Approval P130016 S046

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: P130016S046
• Classification Name: None
• PMA: P130016
• Supplement: S046

Supplemental Filings

Supplement Number	Date	Supplement Type
P130016		Original Filing
S051	2022-09-07	Real-time Process
S050	2022-07-11	30-day Notice
S049	2022-05-02	Normal 180 Day Track No User Fee
S048
S047	2022-02-01	30-day Notice
S046
S045	2020-11-12	30-day Notice
S044
S043	2020-01-14	Special (immediate Track)
S042
S041
S040
S039
S038	2019-06-07	Normal 180 Day Track No User Fee
S037	2019-01-30	30-day Notice
S036	2018-11-01	Normal 180 Day Track
S035	2018-08-13	30-day Notice
S034	2018-02-15	30-day Notice
S033	2018-01-02	30-day Notice
S032	2017-11-13	Normal 180 Day Track
S031	2017-07-17	30-day Notice
S030	2017-06-21	Real-time Process
S029	2017-06-07	30-day Notice
S028	2017-05-23	Normal 180 Day Track
S027	2017-05-16	30-day Notice
S026	2017-04-24	30-day Notice
S025	2017-04-10	30-day Notice
S024	2017-03-23	30-day Notice
S023	2017-02-27	30-day Notice
S022	2016-10-12	Normal 180 Day Track
S021	2016-10-06	Normal 180 Day Track No User Fee
S020	2016-07-25	30-day Notice
S019	2016-06-15	135 Review Track For 30-day Notice
S018	2016-02-24	30-day Notice
S017	2016-02-24	Normal 180 Day Track
S016	2016-02-08	Normal 180 Day Track
S015	2016-01-06	30-day Notice
S014	2016-01-05	30-day Notice
S013	2015-12-04	30-day Notice
S012	2015-11-23	Normal 180 Day Track
S011	2015-02-13	30-day Notice
S010	2014-12-24	30-day Notice
S009	2014-09-24	Normal 180 Day Track No User Fee
S008	2014-07-23	30-day Notice
S007	2014-06-09	Real-time Process
S006	2014-05-16	30-day Notice
S005	2014-05-01	Normal 180 Day Track
S004	2014-04-18	Normal 180 Day Track No User Fee
S003	2014-04-18	Normal 180 Day Track No User Fee
S002	2014-04-02	Real-time Process
S001	2014-03-28	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
09321502012089	P130016	000
09321502023979	P130016	000
09321502023962	P130016	000
09321502023313	P130016	000
09321502023306	P130016	000
09321502025034	P130016	000
09321502024082	P130016	000
09321502024068	P130016	000
09321502024051	P130016	000
09321502024044	P130016	000
09321502024037	P130016	000
09321502024020	P130016	000
09321502024013	P130016	000
09321502024006	P130016	000
09321502023337	P130016	000
09321502023320	P130016	000
09321502023986	P130016	000
09321502023993	P130016	000
09321502027441	P130016	000
09321502025065	P130016	000
09321502025041	P130016	000
09321502025027	P130016	000
09321502025010	P130016	000
09321502025003	P130016	000
09321502024990	P130016	000
09321502024983	P130016	000
09321502024976	P130016	000
09321502024969	P130016	000
09321502024952	P130016	000
09321502024945	P130016	000
09321502024938	P130016	000
09321502024099	P130016	000
09321502024075	P130016	000
09321502022859	P130016	000