FDA.reportPublic FDA data

PMA P890023S034

Device
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S034
Product code
LPM
Decision date
2018-08-01
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for a modification to the packaging formulation and process used in the packaging of ocufilcon D Soft (hydrophilic) extended wear contact lenses.

Current openFDA PMA Record#

Device
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S034
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-08-01
Decision code
APPR
Date received
2018-06-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a modification to the packaging formulation and process used in the packaging of ocufilcon D Soft (hydrophilic) extended wear contact lenses.