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Device | Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P010019 |
Supplement Number | S078 |
Date Received | 06/04/2021 |
Decision Date | 08/27/2021 |
Product Code |
LPM |
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 CIBA VISION Asia Manufacturing and Logistics Pte Ltd., 133 Tuas South Avenue 3, Singapore 637550 Manufacturing Operation: Repackaging. |