SOLESTA INJECTABLE GEL

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P100014

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the solesta. This device is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (e. G. , diet, fiber therapy, anti-motility medications).

DeviceSOLESTA INJECTABLE GEL
Classification NameAgent, Bulking, Injectable For Gastro-urology Use
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantPalette Life Sciences
Date Received2010-04-09
Decision Date2011-05-27
Notice Date2011-06-15
PMAP100014
SupplementS
Product CodeLNM
Docket Number11M-0445
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100014Original Filing
S033 2022-02-17 30-day Notice
S032 2021-09-07 135 Review Track For 30-day Notice
S031 2021-05-03 Normal 180 Day Track No User Fee
S030 2020-12-04 30-day Notice
S029 2020-11-13 30-day Notice
S028 2020-10-14 30-day Notice
S027 2020-06-09 30-day Notice
S026
S025 2020-01-29 30-day Notice
S024
S023 2019-11-21 30-day Notice
S022 2019-08-16 30-day Notice
S021 2018-08-16 30-day Notice
S020 2018-04-26 135 Review Track For 30-day Notice
S019 2016-12-19 30-day Notice
S018 2016-09-12 135 Review Track For 30-day Notice
S017 2014-11-19 Normal 180 Day Track No User Fee
S016 2014-09-10 30-day Notice
S015 2014-07-07 30-day Notice
S014 2014-06-12 135 Review Track For 30-day Notice
S013 2014-05-28 135 Review Track For 30-day Notice
S012 2013-11-26 135 Review Track For 30-day Notice
S011 2013-11-04 Normal 180 Day Track No User Fee
S010
S009 2013-04-01 Normal 180 Day Track No User Fee
S008 2012-11-20 30-day Notice
S007 2012-03-30 30-day Notice
S006 2012-03-23 30-day Notice
S005 2012-03-20 Normal 180 Day Track No User Fee
S004 2011-10-13 Normal 180 Day Track No User Fee
S003 2011-08-15 30-day Notice
S002 2011-07-12 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
00365649850035 P100014 014
00850004725016 P100014 021

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