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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSOLESTA INJECTABLE GEL
Classification Nameagent, bulking, injectable for gastro-urology use
ApplicantSALIX PHARMACEUTICALS, INC.
PMA NumberP100014
Date Received04/09/2010
Decision Date05/27/2011
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 11M-0445
Notice Date 06/15/2011
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00605826
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 S005 S006 S007 
S008 
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