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. |
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Device | AcrySof ReSTOR Posterior Chamber Intraocular Lenses |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S094 |
Date Received | 05/29/2020 |
Decision Date | 02/18/2021 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a contract sterilization site located at Synergy Health Sterilisation UK Ltd., Unit 1, Alpha Court, Capitol Park, Thorne, Doncaster DN8 5TZ United Kingdom. |
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