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

DeviceP160040S005
Classification NameNone
Applicant
PMAP160040
SupplementS005

Supplemental Filings

Supplement NumberDateSupplement Type
P160040Original 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 IDPMASupp
00850052003685 P160040 004
00850052003739 P160040 006
00810022732571 P160040 006

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