Biofinity XR Toric, Biofinity Toric Multifocal
FDA premarket approval P080011/S148 · decided 2022-08-18
Approval details
- PMA number
- P080011
- Supplement
- S148
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric, Biofinity Toric Multifocal
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-07-21
- Decision date
- 2022-08-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of Biofinity XR Toric and Biofinity Toric Multifocal N-Type lenses on the Biofinity Made-to-Order (MTO) manufacturing Line 3 at the CooperVision, Inc. facility in Scottsville, NY. Biofinity.
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