FDA.reportPublic FDA data

PMA P890023S042

Device
ocufilcon D soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S042
Product code
LPM
Decision date
2020-02-14
Generic name
Lenses, soft contact, extended wear
Approval order statement
Implementation of the manufacture of Biomedics 55 Asphere extended wear contact lenses with a base curve of 8.8 mm at the CooperVision facility located in Scottsville, New York.

Current openFDA PMA Record#

Device
ocufilcon D soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S042
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-02-14
Decision code
OK30
Date received
2020-01-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of the manufacture of Biomedics 55 Asphere extended wear contact lenses with a base curve of 8.8 mm at the CooperVision facility located in Scottsville, New York.