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: PMMA VS-100 MP PC IO
• Classification Name: intraocular lens
• Generic Name: ntraocular lenses(iol)21 cfr 886.3600/class iii
• Regulation Number: 886.3600
• Applicant: ALCON LABORATORIES
• PMA Number: P810032
• Supplement Number: S051
• Date Received: 10/18/2004
• Decision Date: 03/04/2005
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the use of an additional supplier of polymethylmethacrylate (pmma) for the pmma iols.