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: AMO TECNIS ACRYLIC LENS, MODEL ZA9003
• Classification Name: intraocular lens
• Generic Name: posterior chamber intraocular lenses
• Regulation Number: 886.3600
• Applicant: ADVANCED MEDICAL OPTICS, INC.
• PMA Number: P990080
• Supplement Number: S020
• Date Received: 02/20/2007
• Decision Date: 03/20/2007
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Reduction of cycle time on lathes used in the manufacturing facility in anasco, puerto rico.