MiSight 1 Day (omafilcon A)
FDA premarket approval P180035/S022 · decided 2024-08-01
Approval details
- PMA number
- P180035
- Supplement
- S022
- 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
- 2024-07-03
- Decision date
- 2024-08-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- the use of a new fan motor on Getinge Autoclaves at the CooperVision Manufacturing, Ltd. facility in Chandlers Ford, UK
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.