H55 HYDROPHILIC CONTACT LENS
FDA premarket approval P890023/S054 · decided 2025-03-17
Approval details
- PMA number
- P890023
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- H55 HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2025-02-21
- Decision date
- 2025-03-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- introduction of a new airborne particle counter at CooperVisions manufacturing facility located in Juana Diaz, Puerto Rico
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