Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: DEFLUX INJECTABLE GEL
• Classification Name: agent, bulking, injectable for gastro-urology use
• Generic Name: injectable bulking agent
• Applicant: Q-MED SCANDINAVIA, INC.
• PMA Number: P000029
• Supplement Number: S044
• Date Received: 04/25/2008
• Decision Date: 05/23/2008
• Product Code: LNM [ Registered Establishments with LNM ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Additional sterility testing laboratory.