PMA P170035S014

Device
Eureka!™ Monthly (samfilcon A) Contact Lenses
Applicant
Bausch and Lomb, Inc.,
Product code
LPM
Decision date
2022-01-24
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for addition of a private label trade name.

Current openFDA PMA Record#

Device
Eureka!™ Monthly (samfilcon A) Contact Lenses
Applicant
Bausch and Lomb, Inc.,
PMA number
P170035
Supplement
S014
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2022-01-24
Decision code
APPR
Date received
2021-07-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for addition of a private label trade name.