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Device | AIR OPTIX plus HYDRAGLYDE 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 | S054 |
Date Received | 03/24/2017 |
Decision Date | 04/21/2017 |
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 variable sampling plan for the lens power testing during in-process and final product quality control testing of AIR OPTIX plus HydraGlyde (lotrafilcon B) soft contact lenses for daily and extended wear. |