P160054S022

None

FDA Premarket Approval P160054 S022

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

DeviceP160054S022
Classification NameNone
Applicant
PMAP160054
SupplementS022

Supplemental Filings

Supplement NumberDateSupplement Type
P160054Original Filing
S023 2019-08-27 30-day Notice
S022
S021
S020 2019-07-29 30-day Notice
S019 2019-06-19 Normal 180 Day Track No User Fee
S018 2019-02-19 Normal 180 Day Track
S017
S016 2018-12-13 Real-time Process
S015 2018-11-19 Normal 180 Day Track No User Fee
S014 2018-10-29 30-day Notice
S013 2018-09-04 Normal 180 Day Track
S012 2018-08-31 Normal 180 Day Track
S011 2018-08-16 Real-time Process
S010 2018-05-16 Special (immediate Track)
S009 2018-05-04 30-day Notice
S008 2018-05-03 Panel Track
S007 2018-04-16 Normal 180 Day Track
S006 2018-04-12 Real-time Process
S005 2018-03-16 Normal 180 Day Track
S004 2018-03-14 135 Review Track For 30-day Notice
S003 2018-01-08 30-day Notice
S002 2017-09-13 30-day Notice
S001 2017-09-08 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00813024013082 P160054 005
00813024013075 P160054 005
00813024013082 P160054 005
00813024013075 P160054 005
05415067030818 P160054 006
05415067030825 P160054 006
05415067030801 P160054 006
05415067030368 P160054 007
05415067030269 P160054 013
05415067031105 P160054 016

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