comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S189 · decided 2025-06-23
Approval details
- PMA number
- P080011
- Supplement
- S189
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-06-02
- Decision date
- 2025-06-23
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- modify the manufacturing process to extend the shelf-life of NVP materials from 3 months to 6 months and remove the retest requirement at CooperVisionÂ’smanufacturing facilities located in Hamble, UK, Scottsville, NY, and Juana Diaz, PR
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