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: MODELS UV42D2 AND U642B1 INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: OPTICAL RADIATION CORP.
• PMA Number: P830056
• Supplement Number: S074
• Date Received: 02/19/1993
• Decision Date: 05/17/1994
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• Expedited Review Granted?: No
• Combination Product: No