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: ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES
• Classification Name: intraocular lens
• Generic Name: intraocular lenses
• Regulation Number: 886.3600
• Applicant: ALCON LABORATORIES
• PMA Number: P930014
• Supplement Number: S004
• Date Received: 10/24/1996
• Decision Date: 04/22/1997
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for labeling changes for the acrysof(r) molded acrylic iols.