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: OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Generic Name: anterior chamber intraocular lens
• Regulation Number: 886.3600
• Applicant: BAUSCH & LOMB
• PMA Number: P880090
• Supplement Number: S021
• Date Received: 03/29/2004
• Decision Date: 05/27/2004
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: location change: sterilizer
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a sterilization site located at cosmed, inc. , plainfield, new jersey.