MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA premarket approval P180035/S020 · decided 2024-07-10
Approval details
- PMA number
- P180035
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- 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.
- Date received
- 2024-04-16
- Decision date
- 2024-07-10
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval of the revised protocol for the MiSight 1 Day Safety post-approval study (PAS)
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