Biofinity (comflicon A)
FDA premarket approval P080011/S168 · decided 2024-07-23
Approval details
- PMA number
- P080011
- Supplement
- S168
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity (comflicon A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2024-06-24
- Decision date
- 2024-07-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- implementation of a harmonized raw material specification at the CooperVision Hamble, UK and Scottsville, NY facilities and the introduction of a Gas Chromatography Purity Test Method at the Hamble, UK facility
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