MiSight 1 day (omafilcon A)
FDA premarket approval P180035/S017 · decided 2023-04-24
Approval details
- PMA number
- P180035
- Supplement
- S017
- 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
- 2023-03-27
- Decision date
- 2023-04-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Manufacture of MiSight 1 Day (omafilcon A) product on Dry Line HF and Wet Line HVF at the Warrior Close manufacturing facility in Chandlers Ford, Eastleigh, UK.
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