comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
FDA premarket approval P080011/S093 · decided 2019-05-31
Approval details
- PMA number
- P080011
- Supplement
- S093
- 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
- 2019-05-02
- Decision date
- 2019-05-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Alternate manufacturer for a raw material for use in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the CooperVision Hamble, United Kingdom and Juana Diaz, Puerto Rico manufacturing sites.
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