Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: LOTRAFILCON B SOFT CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P010019
• Supplement Number: S032
• Date Received: 05/04/2012
• Decision Date: 05/22/2012
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER FOR BETACON MACROMER USED IN THE FORMULATION OF LOTRAFILCON B SOFT CONTACT LENSES.