PMA P000029S076

Device: DEFLUX INJECTABLE GEL
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S076
Product code: LNM
Decision date: 2014-05-08
Classification: Agent, Bulking, Injectable For Gastro-urology Use
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Approval order statement: APPROVAL FOR THE INTRODUCTION OF IN-HOUSE PRODUCED WATER FOR INJECTION (WFI), AS WELL AS CLEARANCE FOR THE USE OF PHARMACEUTICAL GRADE NAOH AND HCL, RATHER THAN THE GRADE CURRENTLY USED BY THE FIRM.

Current openFDA PMA Record#

Device: DEFLUX INJECTABLE GEL
Applicant: Palette Life Sciences
PMA number: P000029
Supplement: S076
Product code: LNM
Generic name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Decision date: 2014-05-08
Decision code: APPR
Date received: 2013-11-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE INTRODUCTION OF IN-HOUSE PRODUCED WATER FOR INJECTION (WFI), AS WELL AS CLEARANCE FOR THE USE OF PHARMACEUTICAL GRADE NAOH AND HCL, RATHER THAN THE GRADE CURRENTLY USED BY THE FIRM.