PMA P080011S093

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S093
Product code: LPM
Decision date: 2019-05-31
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Alternate manufacturer for a raw material for use in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the CooperVision Hamble, United Kingdom and Juana Diaz, Puerto Rico manufacturing sites.

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S093
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-05-31
Decision code: OK30
Date received: 2019-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate manufacturer for a raw material for use in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the CooperVision Hamble, United Kingdom and Juana Diaz, Puerto Rico manufacturing sites.