FDA.reportPublic FDA data

PMA P100014S027

Device
Solesta Injectable Gel
Applicant
Palette Life Sciences
PMA number
P100014
Supplement
S027
Product code
LNM
Decision date
2020-07-09
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
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 .

Current openFDA PMA Record#

Device
Solesta Injectable Gel
Applicant
Palette Life Sciences
PMA number
P100014
Supplement
S027
Product code
LNM
Generic name
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date
2020-07-09
Decision code
OK30
Date received
2020-06-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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 .