PMA P890023S021

Device
OCUFILCON D EXTENDED-WEAR LENSES
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S021
Product code
LPM
Decision date
2015-01-09
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.

Current openFDA PMA Record#

Device
OCUFILCON D EXTENDED-WEAR LENSES
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S021
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2015-01-09
Decision code
APPR
Date received
2013-11-13
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.