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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceSOLESTA INJECTABLE GEL
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 East Cota Street
Suite 402
Santa Barbara, CA 93101
PMA NumberP100014
Date Received04/09/2010
Decision Date05/27/2011
Product Code LNM 
Docket Number 11M-0445
Notice Date 06/15/2011
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00605826
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S016 S009  S013 S002 S003 S004 S005 S006 S007 S008 S011 
S012 S015 S019 S014 S017 S018 S027 S032 S031 S033 S034 S020 
S021 S028 S023 S024 S025 S026 S022 S035 S029 S030 
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