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: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
• Classification Name: lens,intraocular,accommodative
• Regulation Number: 886.3600
• Applicant: BAUSCH & LOMB, INC.
• PMA Number: P030002
• Supplement Number: S025
• Date Received: 08/18/2011
• Decision Date: 09/15/2011
• Product Code: NAA [ Registered Establishments with NAA ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Refurbishment of an autoclave sterilizer.