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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 NumberS034
Date Received06/20/2023
Decision Date07/11/2023
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  
Replacement of the current inkjet printer used for printing the Unique Device Identifier (UDI) 2D-barcode on the device carton with a new printer and vision system that will print both the UDI 2D-barcode and associated batch information on the device carton.
Post-Approval StudyShow Report Schedule and Study Progress
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