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Device | Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As |
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 | S067 |
Date Received | 07/13/2018 |
Decision Date | 08/08/2018 |
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 Produce spherical AIR OPTIX plus HYDRAGLYDE lotrafilcon B contact lenses on an additional production platform. |