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: VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
• Classification Name: aid, surgical, viscoelastic
• Generic Name: sterile viscoelastric material
• Regulation Number: 886.4275
• Applicant: ALCON LABORATORIES
• PMA Number: P840064
• Supplement Number: S031
• Date Received: 05/18/2006
• Decision Date: 06/16/2006
• Product Code: LZP [ Registered Establishments with LZP ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Change in sterilization process parameters.