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Device | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses |
Generic Name | Daily wear soft contact lens to reduce the progression of myopia |
Applicant | CooperVision, Inc. 5870 Stoneridge Drive Suite 1 Pleasanton, CA 94588 |
PMA Number | P180035 |
Supplement Number | S002 |
Date Received | 01/09/2020 |
Decision Date | 02/04/2020 |
Product Code |
QIT |
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 Manufacture of MiSight I Day lenses on Dry Line HC at the CooperVision Manufacturing, Ltd. facility in Chandlers Ford, United Kingdom. |