P100046S011

None

FDA Premarket Approval P100046 S011

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: P100046S011
• Classification Name: None
• PMA: P100046
• Supplement: S011

Supplemental Filings

Supplement Number	Date	Supplement Type
P100046		Original Filing
S013	2022-03-01	Normal 180 Day Track
S012	2020-08-03	30-day Notice
S011
S010	2018-12-28	Normal 180 Day Track No User Fee
S009	2018-12-10	30-day Notice
S008	2016-09-01	30-day Notice
S007	2016-06-22	Normal 180 Day Track No User Fee
S006	2014-11-21	Real-time Process
S005	2014-05-21	Normal 180 Day Track No User Fee
S004	2014-04-15	Normal 180 Day Track No User Fee
S003	2013-07-12	Normal 180 Day Track
S002	2013-05-13	30-day Notice
S001	2012-02-14	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
00818354010596	P100046	003
00818354010558	P100046	003
00818354010503	P100046	003
00818354010206	P100046	003
30840143902318	P100046	003
30840143902141	P100046	003
30840143903018	P100046	003