Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear
FDA premarket approval P080011/S187 · decided 2025-05-02
Approval details
- PMA number
- P080011
- Supplement
- S187
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-04-10
- Decision date
- 2025-05-02
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- upgrade of an existing optical measurement device at CooperVisions manufacturing facility located in Hamble, UK
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