P130022S034

None

FDA Premarket Approval P130022 S034

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

DeviceP130022S034
Classification NameNone
Applicant
PMAP130022
SupplementS034

Supplemental Filings

Supplement NumberDateSupplement Type
P130022Original Filing
S041 2021-02-12 Real-time Process
S040 2021-02-09 Normal 180 Day Track
S039
S038 2020-11-09 Real-time Process
S037
S036
S035
S034
S033 2020-04-27 Special (immediate Track)
S032
S031 2020-01-03 Real-time Process
S030
S029
S028 2019-08-12 Normal 180 Day Track
S027 2019-08-12 Real-time Process
S026 2019-07-29 Real-time Process
S025 2019-05-24 Real-time Process
S024
S023 2019-04-19 Real-time Process
S022
S021
S020
S019 2018-08-13 Normal 180 Day Track
S018 2018-07-23 Real-time Process
S017 2017-09-12 Normal 180 Day Track No User Fee
S016 2017-09-06 30-day Notice
S015 2017-07-14 30-day Notice
S014 2017-07-03 Normal 180 Day Track
S013 2017-05-16 Normal 180 Day Track
S012 2017-02-01 30-day Notice
S011 2016-12-19 30-day Notice
S010 2016-10-20 Normal 180 Day Track No User Fee
S009 2016-09-26 Real-time Process
S008 2016-05-02 Real-time Process
S007 2016-04-11 135 Review Track For 30-day Notice
S006 2016-03-16 30-day Notice
S005 2016-03-16 Real-time Process
S004 2015-11-23 Normal 180 Day Track
S003
S002 2015-09-04 Real-time Process
S001 2015-09-02 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00813426020428 P130022 004
00813426020398 P130022 004
00813426020473 P130022 004
00813426020480 P130022 004
00813426020466 P130022 004

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