|
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 | S006 |
Date Received | 04/17/2020 |
Decision Date | 06/25/2020 |
Product Code |
QIT |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in refractive index specification. |