P160042S010

None

FDA Premarket Approval P160042 S010

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

DeviceP160042S010
Classification NameNone
Applicant
PMAP160042
SupplementS010

Supplemental Filings

Supplement NumberDateSupplement Type
P160042Original Filing
S012 2020-07-15 Real-time Process
S011 2020-01-22 Real-time Process
S010
S009 2019-05-06 30-day Notice
S008
S007
S006
S005
S004 2018-05-29 Normal 180 Day Track
S003 2017-12-20 Normal 180 Day Track
S002
S001 2017-08-14 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
66980800001000 P160042 000
66980800001000 P160042 000
66980800001017 P160042 003
66980800001017 P160042 003
66980800001024 P160042 004

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