P080013S005

None

FDA Premarket Approval P080013 S005

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: P080013S005
• Classification Name: None
• PMA: P080013
• Supplement: S005

Supplemental Filings

Supplement Number	Date	Supplement Type
P080013		Original Filing
S024	2022-09-07	30-day Notice
S023	2021-10-18	30-day Notice
S022
S021	2020-08-17	30-day Notice
S020	2020-06-23	Special (immediate Track)
S019
S018	2019-12-30	Normal 180 Day Track No User Fee
S017	2019-06-11	30-day Notice
S016	2018-10-29	30-day Notice
S015	2017-11-30	Normal 180 Day Track No User Fee
S014	2017-07-28	Normal 180 Day Track No User Fee
S013	2016-04-18	Real-time Process
S012
S011	2015-02-02	Normal 180 Day Track No User Fee
S010
S009	2013-06-04	135 Review Track For 30-day Notice
S008	2013-03-25	Normal 180 Day Track No User Fee
S007	2011-07-20	Special (immediate Track)
S006	2011-03-21	Normal 180 Day Track No User Fee
S005
S004	2011-03-02	Normal 180 Day Track No User Fee
S003	2010-01-20	Normal 180 Day Track
S002	2009-10-14	Real-time Process
S001	2009-10-06	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
30381780000048	P080013	009
30381780000031	P080013	009