comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S076 · decided 2018-07-02
Approval details
- PMA number
- P080011
- Supplement
- S076
- Supplement type
- 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
- 2018-06-11
- Decision date
- 2018-07-02
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of the capability to produce Biofinity XR Toric in 5° axis increment steps on Biofinity Line 3 at the CooperVision, Inc. manufacturing facility in Hamble, UK.
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