PMA P000029S098

Device: Deflux® Injectable Gel
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S098
Product code: LNM
Decision date: 2024-05-31
Classification: Gastroenterology, Urology
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: For labeling changes including addition of new safety information in the instructions for use (IFU), exterior packaging, and parent/caregiver brochure

Current openFDA PMA Record#

Device: Deflux® Injectable Gel
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S098
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2024-05-31
Decision code: APPR
Date received: 2024-05-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: For labeling changes including addition of new safety information in the instructions for use (IFU), exterior packaging, and parent/caregiver brochure