P160012S001

None

FDA Premarket Approval P160012 S001

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: P160012S001
• Classification Name: None
• PMA: P160012
• Supplement: S001

Supplemental Filings

Supplement Number	Date	Supplement Type
P160012		Original Filing
S006	2022-05-16	Real-time Process
S005
S004	2020-04-16	30-day Notice
S003
S002
S001

NIH GUDID Devices

Device ID	PMA	Supp
00883873824610	P160012	002
00883873824603	P160012	002
00883873824597	P160012	002