MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA premarket approval P180035/S004 · decided 2021-07-12
Approval details
- PMA number
- P180035
- Supplement
- S004
- 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
- 2020-01-15
- Decision date
- 2021-07-12
- Days to decision
- 544 days
- Decision code
- APPR
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval of the protocol for the MiSight®1 Day Safety Post Approval Study (PAS) protocol.
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