PMA P100014S032

Device: SOLESTA Injectable Gel
Applicant: Palette Life Sciences
PMA number: P100014
Supplement: S032
Product code: LNM
Decision date: 2022-03-22
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: Approval for a new alternate contract sterility testing laboratory for the DEFLUX Injectable Gel and the Solestra Injectable Gel.

Current openFDA PMA Record#

Device: SOLESTA Injectable Gel
Applicant: Palette Life Sciences
PMA number: P100014
Supplement: S032
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2022-03-22
Decision code: APPR
Date received: 2021-09-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new alternate contract sterility testing laboratory for the DEFLUX Injectable Gel and the Solestra Injectable Gel.