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: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
• Classification Name: aid, surgical, viscoelastic
• Regulation Number: 886.4275
• Applicant: ABBOTT MEDICAL OPTICS INC
• PMA Number: P810031
• Supplement Number: S040
• Date Received: 08/01/2011
• Decision Date: 08/31/2011
• Product Code: LZP [ Registered Establishments with LZP ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Implementation of a new pure steam generator.