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PMA P890023S028

Device
ocufilcon D Sift (Hydrophilie) Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S028
Product code
LPM
Decision date
2017-12-19
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for a change in the test specifications of the saline solutions that are manufactured at the CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico and used in the packaging of ocufilcon D Soft (Hydrophilic) Contact Lenses in blister containers.

Current openFDA PMA Record#

Device
ocufilcon D Sift (Hydrophilie) Contact Lenses
Applicant
The Cooper Companies
PMA number
P890023
Supplement
S028
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2017-12-19
Decision code
APPR
Date received
2017-08-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change in the test specifications of the saline solutions that are manufactured at the CooperVision Caribbean Corporation manufacturing facility in Juana Diaz, Puerto Rico and used in the packaging of ocufilcon D Soft (Hydrophilic) Contact Lenses in blister containers.