Biofinity Sphere and Sphere XR, Biofinity Energys Asphere, Biofinity Toric, Biofinity Torie XR, Biofinity Multifoeal
FDA premarket approval P080011/S162 · decided 2024-05-23
Approval details
- PMA number
- P080011
- Supplement
- S162
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere and Sphere XR, Biofinity Energys Asphere, Biofinity Toric, Biofinity Torie XR, Biofinity Multifoeal
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2024-05-08
- Decision date
- 2024-05-23
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- introduction of a new Getinge autoclave and steam generators at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom
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