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 IQ ReSTOR Posterior Chamber Intraocular Lens |
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 | S097 |
Date Received | 11/25/2020 |
Decision Date | 12/17/2020 |
Product Code |
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 Introduction of the Turbidimetric Test Method for the Detection of Endotoxin levels for PMMA, AcrySof and AcrySof ReSTOR Intraocular Lenses (IOLs), AcrySert and UltraSert Lens Delivery Systems and Purified Water at Alcon Huntington West Virginia. |
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