Biofinity XR Toric (comfilcon A)
FDA premarket approval P080011/S086 · decided 2019-01-11
Approval details
- PMA number
- P080011
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity XR Toric (comfilcon A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-12-17
- Decision date
- 2019-01-11
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of the option to perform the lathe cut as a 2-step process in the manufacture of the Biofinity XR Toric (comfilcon A) Soft (hydrophilic) Extended Wear Contact Lenses.
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