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 A Soft Contact Lenses for Daily and Extended wear
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Alcon Laboratories, Inc.; 6201 South Freeway; Fort Worth, TX 76134-2099
• PMA Number: P010019
• Supplement Number: S059
• Date Received: 08/29/2017
• Decision Date: 09/25/2017
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Update to the Manufacturing Execution System for manufacture of lotrafilcon A contact lenses.