Biofinity Toric Multifocal
FDA premarket approval P080011/S139 · decided 2022-06-09
Approval details
- PMA number
- P080011
- Supplement
- S139
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Toric Multifocal
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-02-25
- Decision date
- 2022-06-09
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Aapproval for the addition of the CooperVision, Inc. facility located at 711 North Road, Scottsville, New York 14546 as a manufacturing site for Biofinity Torie Multi focal.
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