CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
FDA premarket approval P080011/S055 · decided 2017-02-27
Approval details
- PMA number
- P080011
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-02-02
- Decision date
- 2017-02-27
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Acceptance for the validation of Biofinity Line 3 to manufacture Biofinity XR Toric High Minus Power Lenses at the CooperVision Inc. Hamble, UK manufacturing facility.
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