PMA P080011S151

Device: BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S151
Product code: LPM
Decision date: 2022-12-07
Generic name: Lenses, soft contact, extended wear
Approval order statement: Method Validation for Analysis of Polymerization Mixture by GC at the CooperVision manufacturing Puerto Rico LLC., at Juana Diaz facility.

Current openFDA PMA Record#

Device: BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S151
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-12-07
Decision code: OK30
Date received: 2022-11-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Method Validation for Analysis of Polymerization Mixture by GC at the CooperVision manufacturing Puerto Rico LLC., at Juana Diaz facility.