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PMA P100014S034

Device
Solesta Injectable Gel
Applicant
Palette Life Sciences
PMA number
P100014
Supplement
S034
Product code
LNM
Decision date
2023-07-11
Classification
Gastroenterology, Urology
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
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.

Current openFDA PMA Record#

Device
Solesta Injectable Gel
Applicant
Palette Life Sciences
PMA number
P100014
Supplement
S034
Product code
LNM
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date
2023-07-11
Decision code
OK30
Date received
2023-06-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.