FDA.reportPublic FDA data

PMA P080011S097

Device
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S097
Product code
LPM
Decision date
2019-09-10
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Introduction of a new flow cytometry analyzer to be used in replacement of the current cytometry analyzer at the CooperVision Caribbean Corporation facility in Juana Diaz, Puerto Rico.

Current openFDA PMA Record#

Device
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S097
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2019-09-10
Decision code
OK30
Date received
2019-08-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a new flow cytometry analyzer to be used in replacement of the current cytometry analyzer at the CooperVision Caribbean Corporation facility in Juana Diaz, Puerto Rico.