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: SOLESTA INJECTABLE GEL
• Classification Name: agent, bulking, injectable for gastro-urology use
• Applicant: OCEANA THERAPEUTICS INC
• PMA Number: P100014
• Supplement Number: S003
• Date Received: 08/15/2011
• Decision Date: 09/09/2011
• 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 
Change in composition of the biological indicator.