PMA P080011S074

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S074
Product code: LPM
Decision date: 2018-10-02
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for the introduction and validation of a new laboratory sterilizer at CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico.

Current openFDA PMA Record#

Device: comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S074
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2018-10-02
Decision code: APPR
Date received: 2018-03-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the introduction and validation of a new laboratory sterilizer at CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico.