FDA.reportPublic FDA data

PMA P890023S031

Device
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S031
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
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S031
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.