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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 NumberS007
Date Received03/30/2012
Decision Date04/12/2012
Product Code LNM 
Advisory Committee Gastroenterology
Clinical TrialsNCT00605826
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF THE POSSIBILITY TO STORE SAMPLES FOR BIOBURDEN ANALYSIS IN A REFRIGERATOR AT A TEMPERATURE OF 5 DEGREE CELSIUS FOR UP TO 18 HOURS BEFORE ANALYSIS.
Post-Approval StudyShow Report Schedule and Study Progress
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