Biofinity Sphere and Biofinity XR Sphere, Biofinity Torie and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energ
FDA premarket approval P080011/S178 · decided 2025-02-04
Approval details
- PMA number
- P080011
- Supplement
- S178
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere and Biofinity XR Sphere, Biofinity Torie and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energ
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-01-08
- Decision date
- 2025-02-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- relocation of a secondary packaging line within the CooperVision, Inc. facility in West Henrietta, New York following a building expansion
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