PMA P080011S098

Device
Pearle Vision Monthly Multifocal
Applicant
CooperVision, Inc.
Product code
LPM
Decision date
2020-01-28
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for the addition of a new private label trade name, Pearle Vision Monthly Multifocal, for the CooperVision comfilcon A soft (hydrophilic) extended wear contact lenses.

Current openFDA PMA Record#

Device
Pearle Vision Monthly Multifocal
Applicant
CooperVision, Inc.
PMA number
P080011
Supplement
S098
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2020-01-28
Decision code
APPR
Date received
2019-08-15
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the addition of a new private label trade name, Pearle Vision Monthly Multifocal, for the CooperVision comfilcon A soft (hydrophilic) extended wear contact lenses.