PMA P850079S063

Device: COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S063
Product code: LPM
Decision date: 2014-02-21
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order 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.

Current openFDA PMA Record#

Device: COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES
Applicant: CooperVision, Inc.
PMA number: P850079
Supplement: S063
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2014-02-21
Decision code: APPR
Date received: 2012-12-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.