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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 Injectable Gel
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 E Cota St.
Suite 402
Santa Barbara, CA 93101
PMA NumberP100014
Supplement NumberS027
Date Received06/09/2020
Decision Date07/09/2020
Product Code LNM 
Advisory Committee Gastroenterology
Clinical TrialsNCT00605826
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Extension of shelf life for a critical raw material due to a change in secondary packaging and the addition of a quality control specification limit for the raw material .
Post-Approval StudyShow Report Schedule and Study Progress
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