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. |
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Device | Solesta Injectable Gel |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Palette Life Sciences 27 East Cota Street Suite 402 Santa Barbara, CA 93101 |
PMA Number | P100014 |
Supplement Number | S034 |
Date Received | 06/20/2023 |
Decision Date | 07/11/2023 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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