FDA.reportPublic FDA data

PMA P890023S045

Device
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S045
Product code
LPM
Decision date
2020-09-22
Generic name
Lenses, soft contact, extended wear
Approval order statement
Qualification of a wet line for the manufacture of Biomedics 55 Asphere (ocufilcon D) extended wear contact lenses with a base curve of 8.6 mm at the CooperVision facility located in Scottsville, New York.

Current openFDA PMA Record#

Device
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S045
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-09-22
Decision code
OK30
Date received
2020-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualification of a wet line for the manufacture of Biomedics 55 Asphere (ocufilcon D) extended wear contact lenses with a base curve of 8.6 mm at the CooperVision facility located in Scottsville, New York.