PMA P890023S043

Device
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S043
Product code
LPM
Decision date
2020-09-01
Generic name
Lenses, soft contact, extended wear
Approval order statement
New water treatment system in the Scotsville facility as part of the facility renovation project.

Current openFDA PMA Record#

Device
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S043
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-09-01
Decision code
OK30
Date received
2020-08-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New water treatment system in the Scotsville facility as part of the facility renovation project.