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: KABI PHARMACIA ONE PIECE LENSES
• Classification Name: intraocular lens
• Generic Name: posterior chamber intraocular lens
• Regulation Number: 886.3600
• Applicant: PHARMACIA, INC.
• PMA Number: P810055
• Supplement Number: S051
• Date Received: 04/15/1991
• Decision Date: 09/20/1994
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No