FDA.reportPublic FDA data

PMA P890023S046

Device
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
The Cooper Companies
Product code
LPM
Decision date
2020-12-10
Generic name
Lenses, soft contact, extended wear
Approval order statement
Addition of a second supplier of a raw material, including changes to the raw material specification, for the Biomedics 55 (ocufilcon D) soft (hydrophilic) contact lenses for extended wear.

Current openFDA PMA Record#

Device
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S046
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-12-10
Decision code
APPR
Date received
2020-09-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Addition of a second supplier of a raw material, including changes to the raw material specification, for the Biomedics 55 (ocufilcon D) soft (hydrophilic) contact lenses for extended wear.