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 Lenses |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S079 |
Date Received | 05/02/2018 |
Decision Date | 07/31/2018 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a second alternate sterilization chamber at the contract sterilization site for the AcrySof® and AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses. |
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