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Device | AcrySof ReSTOR Intraocular Lenses |
Generic Name | Lens, multifocal intraocular |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S077 |
Date Received | 12/21/2017 |
Decision Date | 01/08/2018 |
Product Codes |
HQL MFK |
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 Elimination of a test performed during set-up of the manufacturing of your Acrysof and AcrySof ReSTOR multi-piece intraocular lenses. |