PMA P080011S056

Device: BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S056
Product code: LPM
Decision date: 2017-04-17
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Addition of GEO Specialty Chemicals (GEO) as a secondary supplier of a handling tint for use in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the United Kingdom (UK) and Puerto Rico manufacturing sites.

Current openFDA PMA Record#

Device: BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S056
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2017-04-17
Decision code: OK30
Date received: 2017-03-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of GEO Specialty Chemicals (GEO) as a secondary supplier of a handling tint for use in the manufacture of Biofinity (comfilcon A) soft contact lenses at both the United Kingdom (UK) and Puerto Rico manufacturing sites.