Biofinity toric
FDA premarket approval P080011/S089 · decided 2019-02-21
Approval details
- PMA number
- P080011
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2019-01-10
- Decision date
- 2019-02-21
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Implementation of the Shin Nisson DL-1000 lensmeter at Quality Control 1 testing for use in the manufacture of the Biofinity Toric (comfilcon A) Lenses at the United Kingdom manufacturing site.
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