PMA P180035S016
- Device
- MiSight 1 Day (omafilcon A)
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S016
- Product code
- QIT
- Decision date
- 2023-03-22
- Classification
- Ophthalmic
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Approval order statement
- Introduction of a new high volume impression strip blister tool.
Current openFDA PMA Record#
- Device
- MiSight 1 Day (omafilcon A)
- Applicant
- CooperVision, Inc.
- PMA number
- P180035
- Supplement
- S016
- Product code
- QIT
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Decision date
- 2023-03-22
- Decision code
- OK30
- Date received
- 2023-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of a new high volume impression strip blister tool.