MiSight 1 Day (omafilcon A)
FDA premarket approval P180035/S021 · decided 2024-05-31
Approval details
- PMA number
- P180035
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MiSight 1 Day (omafilcon A)
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Applicant
- CooperVision, Inc.
- Date received
- 2024-05-08
- Decision date
- 2024-05-31
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- the introduction of a secondary packaging line at the CooperVision, Inc. facility in West Henrietta New York
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