Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses
FDA premarket approval N17679/S038 · decided 2017-11-16
Approval details
- PMA number
- N17679
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-10-23
- Decision date
- 2017-11-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Conversion of manufacturing equipment for Preference Sphere (tetrafilcon A) lenses produced at the CooperVision Incorporated manufacturing facility in Scottsville, New York.
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