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 | Single-Piece PMMA Anterior Chamber IOLs |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P880087 |
Supplement Number | S031 |
Date Received | 06/21/2021 |
Decision Date | 12/02/2021 |
Product Code |
HQL |
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 manufacturing site located at PT. CIBA VISION Batam located at Jalan Beringin Kav. #204, Batamindo Industrial Park, Muka Kuning Batam Island, 29433 Indonesia for manufacturing, packaging, and sterilization. |
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