PMA P000029S074

Device: DEFLUX INJECTABLE GEL
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S074
Product code: LNM
Decision date: 2013-05-22
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL FOR UPDATE TO THE INFORMATION ABOUT POST-APPROVAL ADVERSE REACTIONS AND UPDATE ON THE LABELING OF THE SPONSOR NAME AND CONTACT INFORMATION.

Current openFDA PMA Record#

Device: DEFLUX INJECTABLE GEL
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S074
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2013-05-22
Decision code: APPR
Date received: 2013-04-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATE TO THE INFORMATION ABOUT POST-APPROVAL ADVERSE REACTIONS AND UPDATE ON THE LABELING OF THE SPONSOR NAME AND CONTACT INFORMATION.