Biofinity Sphere (comfilcon A)
FDA premarket approval P080011/S163 · decided 2024-06-12
Approval details
- PMA number
- P080011
- Supplement
- S163
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere (comfilcon A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2024-05-15
- Decision date
- 2024-06-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- a software upgrade on the Fill and Close module for the High Volume Biofinity Line 1 at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom
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