P130016S046

None

FDA Premarket Approval P130016 S046

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

DeviceP130016S046
Classification NameNone
Applicant
PMAP130016
SupplementS046

Supplemental Filings

Supplement NumberDateSupplement Type
P130016Original Filing
S047 2022-02-01 30-day Notice
S046
S045 2020-11-12 30-day Notice
S044
S043 2020-01-14 Special (immediate Track)
S042
S041
S040
S039
S038 2019-06-07 Normal 180 Day Track No User Fee
S037 2019-01-30 30-day Notice
S036 2018-11-01 Normal 180 Day Track
S035 2018-08-13 30-day Notice
S034 2018-02-15 30-day Notice
S033 2018-01-02 30-day Notice
S032 2017-11-13 Normal 180 Day Track
S031 2017-07-17 30-day Notice
S030 2017-06-21 Real-time Process
S029 2017-06-07 30-day Notice
S028 2017-05-23 Normal 180 Day Track
S027 2017-05-16 30-day Notice
S026 2017-04-24 30-day Notice
S025 2017-04-10 30-day Notice
S024 2017-03-23 30-day Notice
S023 2017-02-27 30-day Notice
S022 2016-10-12 Normal 180 Day Track
S021 2016-10-06 Normal 180 Day Track No User Fee
S020 2016-07-25 30-day Notice
S019 2016-06-15 135 Review Track For 30-day Notice
S018 2016-02-24 30-day Notice
S017 2016-02-24 Normal 180 Day Track
S016 2016-02-08 Normal 180 Day Track
S015 2016-01-06 30-day Notice
S014 2016-01-05 30-day Notice
S013 2015-12-04 30-day Notice
S012 2015-11-23 Normal 180 Day Track
S011 2015-02-13 30-day Notice
S010 2014-12-24 30-day Notice
S009 2014-09-24 Normal 180 Day Track No User Fee
S008 2014-07-23 30-day Notice
S007 2014-06-09 Real-time Process
S006 2014-05-16 30-day Notice
S005 2014-05-01 Normal 180 Day Track
S004 2014-04-18 Normal 180 Day Track No User Fee
S003 2014-04-18 Normal 180 Day Track No User Fee
S002 2014-04-02 Real-time Process
S001 2014-03-28 30-day Notice

NIH GUDID Devices

Device IDPMASupp
09321502012089 P130016 000
09321502023979 P130016 000
09321502023962 P130016 000
09321502023313 P130016 000
09321502023306 P130016 000
09321502025034 P130016 000
09321502024082 P130016 000
09321502024068 P130016 000
09321502024051 P130016 000
09321502024044 P130016 000
09321502024037 P130016 000
09321502024020 P130016 000
09321502024013 P130016 000
09321502024006 P130016 000
09321502023337 P130016 000
09321502023320 P130016 000
09321502023986 P130016 000
09321502023993 P130016 000
09321502027441 P130016 000
09321502025065 P130016 000
09321502025041 P130016 000
09321502025027 P130016 000
09321502025010 P130016 000
09321502025003 P130016 000
09321502024990 P130016 000
09321502024983 P130016 000
09321502024976 P130016 000
09321502024969 P130016 000
09321502024952 P130016 000
09321502024945 P130016 000
09321502024938 P130016 000
09321502024099 P130016 000
09321502024075 P130016 000
09321502022859 P130016 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.