PMA P890023S020

Device
OCUFILCON D EXTENDED WEAR LENSES
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S020
Product code
LPM
Decision date
2013-12-13
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.

Current openFDA PMA Record#

Device
OCUFILCON D EXTENDED WEAR LENSES
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S020
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2013-12-13
Decision code
OK30
Date received
2013-11-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MANUFACTURING CHANGE TO ADD A NEW QUALITY TEST FOR MANUFACTURING.