Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S149 · decided 2022-10-26
Approval details
- PMA number
- P080011
- Supplement
- S149
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-09-30
- Decision date
- 2022-10-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Modification to optimize the lens transfer module of the manufacturing process for the Biofinity Toric at the CooperVision manufacturing Puerto Rico LLC Juana Diaz facility.
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