|
Device | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear |
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 | S005 |
Date Received | 02/13/2020 |
Decision Date | 03/12/2020 |
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 Introduction of a new Total Organic Carbon (TOC) analyzer for the testing of purified water supplies at the CooperVision Manufacturing, Ltd. facilities located in Hamble, UK and Chandlers Ford, UK. |