PMA P890023S024

Device: OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S024
Product code: LPM
Decision date: 2016-01-11
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: RELOCATION OF THE BIOMEDICS TORIC WET CELL, INSTALLATION OF A NEW TC20I UNIT IN THE BIOMEDICS TORIC QA STATION AND A SOFTWARE UPDATE FOR QA FINAL INSPECTION PRIOR TO MEASUREMENT OF TORIC LENSES.

Current openFDA PMA Record#

Device: OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S024
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2016-01-11
Decision code: OK30
Date received: 2015-12-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: RELOCATION OF THE BIOMEDICS TORIC WET CELL, INSTALLATION OF A NEW TC20I UNIT IN THE BIOMEDICS TORIC QA STATION AND A SOFTWARE UPDATE FOR QA FINAL INSPECTION PRIOR TO MEASUREMENT OF TORIC LENSES.