Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont
FDA premarket approval P080011/S143 · decided 2022-04-27
Approval details
- PMA number
- P080011
- Supplement
- S143
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-03-31
- Decision date
- 2022-04-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Extension of Lens Transfer II process to include non-toric Biofinity cast-moulded products at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom.
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