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U.S. Department of Health and Human Services

Devices@FDA
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Note: 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.
 
DeviceSOLESTA
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 E Cota St.
Suite 402
Santa Barbara, CA 93101
PMA NumberP100014
Supplement NumberS009
Date Received04/01/2013
Decision Date01/14/2014
Product Code LNM 
Advisory Committee Gastroenterology
Clinical TrialsNCT00605826
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REVISION OF THE PRESCRIBING INFORMATION TO INCLUDE 24 AND 26 MONTH DATA.
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
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