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Device | Lotrafilcon A and B soft contact lenses |
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 | S079 |
Date Received | 08/16/2021 |
Decision Date | 09/10/2021 |
Product Code |
LPM |
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 Decommissioning of the strip blister inspection system (SBI) at the packaging lines in the production of Alcon lotrafilcon A and lotrafilcon B soft contact lenses for daily and extended wear. |