P160049S010

None

FDA Premarket Approval P160049 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

DeviceP160049S010
Classification NameNone
Applicant
PMAP160049
SupplementS010

Supplemental Filings

Supplement NumberDateSupplement Type
P160049Original Filing
S013 2021-09-17 Normal 180 Day Track No User Fee
S012 2021-05-07 Normal 180 Day Track No User Fee
S011 2021-01-21 30-day Notice
S010
S009
S008 2020-01-15 30-day Notice
S007 2019-09-03 Special (immediate Track)
S006 2019-05-13 30-day Notice
S005 2019-04-08 30-day Notice
S004
S003 2018-10-01 Normal 180 Day Track No User Fee
S002 2018-01-22 Real-time Process
S001 2017-09-01 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00813132026455 P160049 000
00813132023089 P160049 000
00813132023096 P160049 000
00813132023102 P160049 000
00813132023119 P160049 000
00813132023126 P160049 000
00813132023133 P160049 000
00813132023140 P160049 000
00813132023157 P160049 000
00813132026981 P160049 000
00813132026974 P160049 000
00813132026967 P160049 000
00813132026462 P160049 000
00813132026530 P160049 000
00813132026547 P160049 000
00813132026615 P160049 000
00813132026622 P160049 000
00813132026691 P160049 000
00813132026707 P160049 000
00813132026950 P160049 000
00813132023164 P160049 000
00813132023171 P160049 000
00813132024277 P160049 000
00813132024284 P160049 000
00813132024291 P160049 000
00813132024970 P160049 000
00813132024987 P160049 000
00813132024994 P160049 000
00813132025007 P160049 000
00813132025014 P160049 000
00813132025021 P160049 000
00813132024260 P160049 000
00813132024253 P160049 000
00813132023188 P160049 000
00813132023195 P160049 000
00813132023201 P160049 000
00813132023218 P160049 000
00813132023225 P160049 000
00813132023232 P160049 000
00813132023249 P160049 000
00813132023256 P160049 000
00813132024246 P160049 000
00813132025021 P160049 001
00813132025014 P160049 001
00813132024970 P160049 001
00813132025007 P160049 001
00813132024994 P160049 001
00813132024987 P160049 001
00813132026455 P160049 004
00813132026462 P160049 004
00813132026530 P160049 004
00813132026547 P160049 004
00813132026615 P160049 004
00813132026622 P160049 004
00813132026691 P160049 004
00813132026707 P160049 004
00813132026967 P160049 004
00813132026974 P160049 004
00813132026981 P160049 004
00813132026950 P160049 004

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