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: BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY
• Classification Name: aid, surgical, viscoelastic
• Generic Name: viscoelastic opthalmo-surgical aid agent
• Regulation Number: 886.4275
• Applicant: FERRING PHARMACEUTICALS, INC.
• PMA Number: P960011
• Supplement Number: S013
• Date Received: 01/31/2008
• Decision Date: 02/29/2008
• 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 cycle.