SOLESTA INJECTABLE GEL

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P100014 S016

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

Changes to the environmental limits of the clean rooms used during solesta manufacturing.

• Device: SOLESTA INJECTABLE GEL
• Classification Name: Agent, Bulking, Injectable For Gastro-urology Use
• Generic Name: Agent, Bulking, Injectable For Gastro-urology Use
• Applicant: Palette Life Sciences
• Date Received: 2014-09-10
• Decision Date: 2014-10-10
• PMA: P100014
• Supplement: S016
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Palette Life Sciences 27 East Cota Street suite 402 santa Barbara, CA 93101

Supplemental Filings

Supplement Number	Date	Supplement Type
P100014		Original 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 ID	PMA	Supp
00365649850035	P100014	014
00850004725016	P100014	021