PMA P080011S129

Device: Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S129
Product code: LPM
Decision date: 2021-06-04
Generic name: Lenses, soft contact, extended wear
Approval order statement: Upgrade of sensor and evaluation units used in the extraction and hydration module for the manufacture of the Biofinity (comfilcon A) family of lenses.

Current openFDA PMA Record#

Device: Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S129
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2021-06-04
Decision code: OK30
Date received: 2021-05-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Upgrade of sensor and evaluation units used in the extraction and hydration module for the manufacture of the Biofinity (comfilcon A) family of lenses.