Biofinity Sphere, Biofinity Toric
FDA premarket approval P080011/S158 · decided 2023-12-20
Approval details
- PMA number
- P080011
- Supplement
- S158
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere, Biofinity Toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2023-11-22
- Decision date
- 2023-12-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- upgrades to the software used in the Wet Automated Inspection System for the Biofinity Automated Wet Lines at the CooperVision Manufacturing facility in Puerto Rico
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