P160046S013

None

FDA Premarket Approval P160046 S013

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: P160046S013
• Classification Name: None
• PMA: P160046
• Supplement: S013

Supplemental Filings

Supplement Number	Date	Supplement Type
P160046		Original Filing
S015	2022-10-14	30-day Notice
S014	2022-07-12	30-day Notice
S013
S012	2022-02-16	Special (immediate Track)
S011	2022-01-28	135 Review Track For 30-day Notice
S010	2021-06-14	Panel Track
S009	2021-02-22	Real-time Process
S008	2020-08-26	Real-time Process
S007	2020-01-13	Real-time Process
S006	2019-08-22	Real-time Process
S005	2018-06-18	Real-time Process
S004	2018-04-03	Normal 180 Day Track No User Fee
S003
S002
S001	2017-07-17	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
04015630972784	P160046	000