Solesta (Injectable Gel)

FDA Premarket Approval P100014 S031

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Implement electronic labeling and changes to the labeling including revised contraindication, new warnings and new precautions.

DeviceSolesta (Injectable Gel)
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantPalette Life Sciences
Date Received2021-05-03
Decision Date2021-10-27
PMAP100014
SupplementS031
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101

Supplemental Filings

Supplement NumberDateSupplement Type
P100014Original Filing
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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