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: 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
• Classification Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: ALLERGAN MEDICAL OPTICS
• PMA Number: P880081
• Supplement Number: S022
• Date Received: 09/27/1996
• Decision Date: 03/24/1997
• 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

Approval Order Statement 
Approval for revising the labeling.