comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S085 · decided 2019-09-18
Approval details
- PMA number
- P080011
- Supplement
- S085
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2018-11-23
- Decision date
- 2019-09-18
- Days to decision
- 299 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a Modified Automated Inspection System (AIS) Distortion Tolerance for use in the manufacture of Biofinity toric (comfilcon A) and Biofinity XR toric (comfilcon A) soft contact lenses.
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