Biofinity XR Toric (comfilcon A)
FDA premarket approval P080011/S190 · decided 2025-07-14
Approval details
- PMA number
- P080011
- Supplement
- S190
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric (comfilcon A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-06-18
- Decision date
- 2025-07-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- implementation of a new manufacturing line and sterilization cycle at the Cooper Vision, Inc. facility located in Scottsville, NY, and the transfer of minifiles from the Hamble, UK facility to the Juana Diaz, PR facility
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