PMA P080011S089

Device: Biofinity toric
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S089
Product code: LPM
Decision date: 2019-02-21
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Implementation of the Shin Nisson DL-1000 lensmeter at Quality Control 1 testing for use in the manufacture of the Biofinity Toric (comfilcon A) Lenses at the United Kingdom manufacturing site.

Current openFDA PMA Record#

Device: Biofinity toric
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S089
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-02-21
Decision code: OK30
Date received: 2019-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of the Shin Nisson DL-1000 lensmeter at Quality Control 1 testing for use in the manufacture of the Biofinity Toric (comfilcon A) Lenses at the United Kingdom manufacturing site.