BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear
FDA premarket approval P080011/S151 · decided 2022-12-07
Approval details
- PMA number
- P080011
- Supplement
- S151
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-11-09
- Decision date
- 2022-12-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Method Validation for Analysis of Polymerization Mixture by GC at the CooperVision manufacturing Puerto Rico LLC., at Juana Diaz facility.
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