P160040S005

None

FDA Premarket Approval P160040 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: P160040S005
• Classification Name: None
• PMA: P160040
• Supplement: S005

Supplemental Filings

Supplement Number	Date	Supplement Type
P160040		Original Filing
S010	2022-03-15	30-day Notice
S009	2021-07-12	30-day Notice
S008	2021-07-09	Special (immediate Track)
S007
S006	2019-10-17	Normal 180 Day Track
S005
S004	2018-11-06	Real-time Process
S003	2018-04-12	Normal 180 Day Track No User Fee
S002	2018-03-30	Normal 180 Day Track
S001	2017-12-22	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00850052003685	P160040	004
00850052003739	P160040	006
00810022732571	P160040	006