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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:  S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
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