P160049S014

None

FDA Premarket Approval P160049 S014

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

DeviceP160049S014
Classification NameNone
Applicant
PMAP160049
SupplementS014

Supplemental Filings

Supplement NumberDateSupplement Type
P160049Original Filing
S019 2022-06-14 30-day Notice
S018 2022-04-01 Normal 180 Day Track No User Fee
S017 2022-03-17 30-day Notice
S016
S015 2021-09-29 Panel Track
S014
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
00813132025007 P160049 001
00813132024994 P160049 001
00813132024987 P160049 001
00813132024970 P160049 001
00813132026967 P160049 004
00813132026455 P160049 004
00813132026462 P160049 004
00813132026530 P160049 004
00813132026547 P160049 004
00813132026981 P160049 004
00813132026974 P160049 004
00813132026950 P160049 004
00813132026707 P160049 004
00813132026691 P160049 004
00813132026622 P160049 004
00813132026615 P160049 004
00813132028879 P160049 012
00813132028886 P160049 012
00813132028893 P160049 012
00813132028909 P160049 012
00813132028916 P160049 012
00813132028923 P160049 012
00813132028930 P160049 012
00813132028947 P160049 012
00813132028954 P160049 012
00813132028862 P160049 012
00813132028855 P160049 012
00813132028824 P160049 012
00813132028763 P160049 012
00813132028770 P160049 012
00813132028787 P160049 012
00813132028794 P160049 012
00813132028800 P160049 012
00813132028817 P160049 012
00813132028831 P160049 012
00813132028848 P160049 012
00813132028961 P160049 012
00813132028978 P160049 012
00813132029098 P160049 012
00813132029104 P160049 012
00813132029111 P160049 012
00813132029128 P160049 012
00813132029135 P160049 012
00813132029142 P160049 012
00813132029159 P160049 012
00813132029166 P160049 012
00813132029173 P160049 012
00813132029081 P160049 012
00813132029074 P160049 012
00813132028985 P160049 012
00813132028992 P160049 012
00813132029005 P160049 012
00813132029012 P160049 012
00813132029029 P160049 012
00813132029036 P160049 012
00813132029043 P160049 012
00813132029050 P160049 012
00813132029067 P160049 012
00810060550137 P160049 018
00810060550144 P160049 018
00810060550151 P160049 018
00810060550168 P160049 018
00810060550175 P160049 018
00810060550182 P160049 018
00810060550199 P160049 018
00810060550205 P160049 018
00810060550212 P160049 018
00810060550120 P160049 018
00810060550113 P160049 018
00810060550106 P160049 018
00810060550021 P160049 018
00810060550038 P160049 018
00810060550045 P160049 018
00810060550052 P160049 018
00810060550069 P160049 018
00810060550076 P160049 018
00810060550083 P160049 018
00810060550090 P160049 018
00810060550014 P160049 018
00810060550229 P160049 018
00810060550342 P160049 018
00810060550359 P160049 018
00810060550366 P160049 018
00810060550373 P160049 018
00810060550380 P160049 018
00810060550397 P160049 018
00810060550403 P160049 018
00810060550410 P160049 018
00810060550335 P160049 018
00810060550328 P160049 018
00810060550311 P160049 018
00810060550236 P160049 018
00810060550243 P160049 018
00810060550250 P160049 018
00810060550267 P160049 018
00810060550274 P160049 018
00810060550281 P160049 018
00810060550298 P160049 018
00810060550304 P160049 018
00810060550427 P160049 018

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.