PMA P890023S040

Device
Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S040
Product code
LPM
Decision date
2019-12-18
Generic name
Lenses, soft contact, extended wear
Approval order statement
Implementation of the manufacture of Biomedics 55 Asphere with a base curve of 8.9 mm in the Scottsville facility.

Current openFDA PMA Record#

Device
Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S040
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2019-12-18
Decision code
OK30
Date received
2019-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of the manufacture of Biomedics 55 Asphere with a base curve of 8.9 mm in the Scottsville facility.