P990065S011

None

FDA Premarket Approval P990065 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: P990065S011
• Classification Name: None
• PMA: P990065
• Supplement: S011

Supplemental Filings

Supplement Number	Date	Supplement Type
P990065		Original Filing
S012	2022-03-21	30-day Notice
S011
S010	2016-12-19	Special (immediate Track)
S009	2016-08-08	Normal 180 Day Track No User Fee
S008	2015-01-15	30-day Notice
S007	2014-09-09	Special (immediate Track)
S006	2011-09-19	Normal 180 Day Track No User Fee
S005
S004	2006-05-15	Normal 180 Day Track No User Fee
S003
S002
S001	2003-03-25	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
M425SIRY0010	P990065	006
00850014612146	P990065	015
M425SIRY0010	P990065	015
00850014612030	P990065	015