BIOFINITY SPHERE AND BIOFINITY XR SPHERE
FDA premarket approval P080011/S054 · decided 2017-02-02
Approval details
- PMA number
- P080011
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY SPHERE AND BIOFINITY XR SPHERE
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-01-10
- Decision date
- 2017-02-02
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Addition of Gelest Inc. as a secondary supplier of a raw material to be used in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the UK and Puerto Rico manufacturing sites.
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