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
• Classification Name: agent, bulking, injectable for gastro-urology use
• Applicant: SALIX PHARMACEUTICALS, INC.
• PMA Number: P100014
• Supplement Number: S004
• Date Received: 10/13/2011
• Decision Date: 10/27/2011
• Product Code: LNM [ Registered Establishments with LNM ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval protocol.