Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S105 · decided 2020-04-20
Approval details
- PMA number
- P080011
- Supplement
- S105
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-03-24
- Decision date
- 2020-04-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Installation and qualification of an additional de-ionized (DI) water plant at the CooperVision Manufacturing, Ltd. facility in Hamble, United Kingdom..
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