PMA P080011S203

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S203
Product code: LPM
Decision date: 2026-07-07
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: update a raw material specification, introduce an incoming inspection test method, and modify an existing incoming inspection test method at the facilities in Hamble, United Kingdom, Scottsville, New York, and Juana Diaz, Puerto Rico

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S203
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2026-07-07
Decision code: OK30
Date received: 2026-06-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: update a raw material specification, introduce an incoming inspection test method, and modify an existing incoming inspection test method at the facilities in Hamble, United Kingdom, Scottsville, New York, and Juana Diaz, Puerto Rico