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 1% OVD
• 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: S012
• Date Received: 11/01/2006
• Decision Date: 12/19/2006
• Product Code: LZP [ Registered Establishments with LZP ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: labeling change - trade name
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to change the trade name from biolon to bd1% ovd.