|
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 | S007 |
Date Received | 03/05/2021 |
Decision Date | 03/26/2021 |
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 new reduced quality control sampling plan for lens dry process along with new inspection software. |