MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA premarket approval P180035/S001 · decided 2020-02-05
Approval details
- PMA number
- P180035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2019-11-29
- Decision date
- 2020-02-05
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a repackaging/relabeling site located at CooperVision Manufacturing, Ltd., Mountpark, Unit 1, Wide Lane, Southampton, United Kingdom SO18 2NQ.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.