FDA Premarket Approval P170011 S035

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

Classification NameNone

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original Filing
S038 2022-03-24 30-day Notice
S037 2022-02-09 30-day Notice
S036 2021-12-17 Real-time Process
S034 2021-07-08 Normal 180 Day Track
S033 2021-05-03 Normal 180 Day Track No User Fee
S032 2021-03-31 Normal 180 Day Track
S031 2020-12-31 Normal 180 Day Track
S030 2020-12-30 Normal 180 Day Track
S029 2020-12-15 Normal 180 Day Track No User Fee
S028 2020-10-16 30-day Notice
S025 2020-06-15 Normal 180 Day Track No User Fee
S024 2020-04-10 Real-time Process
S023 2020-03-23 30-day Notice
S022 2020-03-09 30-day Notice
S021 2020-01-28 Real-time Process
S020 2019-12-26 30-day Notice
S019 2019-10-30 30-day Notice
S018 2019-10-25 30-day Notice
S017 2019-09-30 30-day Notice
S016 2019-09-03 30-day Notice
S014 2019-08-26 Special (immediate Track)
S013 2019-05-31 30-day Notice
S012 2019-05-31 30-day Notice
S011 2019-03-15 Normal 180 Day Track No User Fee
S010 2019-03-15 Special (immediate Track)
S008 2018-09-06 Real-time Process
S007 2018-07-31 30-day Notice
S006 2018-07-25 30-day Notice
S005 2018-02-27 Real-time Process
S004 2018-01-09 30-day Notice
S003 2017-12-18 Normal 180 Day Track No User Fee
S002 2017-12-18 Normal 180 Day Track No User Fee
S001 2017-12-05 Real-time Process

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