PMA P890023S039

Device: ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S039
Product code: LPM
Decision date: 2019-11-14
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Installation and validation of two new sterilizers at the CooperVision, Inc., manufacturing facility in Scottsville, New York.

Current openFDA PMA Record#

Device: ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S039
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2019-11-14
Decision code: OK30
Date received: 2019-10-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Installation and validation of two new sterilizers at the CooperVision, Inc., manufacturing facility in Scottsville, New York.