COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
FDA premarket approval P850079/S063 · decided 2014-02-21
Approval details
- PMA number
- P850079
- Supplement
- S063
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-12-10
- Decision date
- 2014-02-21
- Days to decision
- 438 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR THE MANUFACTURE OF THE DEVICE ON ANOTHER MANUFACTURING LINE AND FURTHER THAT ORDERS WITH LOW VOLUME REQUIREMENTS WILL BE LATHED ON THE FRONT SURFACE, RATHER THAN FULLY MOLDED AS LARGE VOLUME ORDERS ARE.
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