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: DUOVISC VISCOELASTIC SYSTEM
• Classification Name: aid, surgical, viscoelastic
• Generic Name: elastic system
• Regulation Number: 886.4275
• Applicant: ALCON LABORATORIES
• PMA Number: P840064
• Supplement Number: S014
• Date Received: 05/30/1995
• Decision Date: 08/02/1995
• Product Code: LZP [ Registered Establishments with LZP ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for a modification to the duovisc package insert to allow for the use of both devices in a single ophthalmic procedure.