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: RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES
• Classification Name: lens, multifocal intraocular
• Generic Name: 21 cfr 886.3600 intraocular lens(iol)
• Regulation Number: 886.3600
• Applicant: ALCON RESEARCH, LTD.
• PMA Number: P040020
• Supplement Number: S013
• Date Received: 02/20/2009
• Decision Date: 03/16/2009
• Product Code: MFK [ Registered Establishments with MFK ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Introduction of an expiration date for perkadox-16.