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: DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD)
• Classification Name: aid, surgical, viscoelastic
• Generic Name: sterile viscoelastric material
• Regulation Number: 886.4275
• Applicant: ALCON LABORATORIES
• PMA Number: P840064
• Supplement Number: S048
• Date Received: 01/05/2012
• Decision Date: 02/03/2012
• 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: No

Approval Order Statement 
Change in the sterilization process.