PMA P950018S015

Device
PERFLUORON
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S015
Product code
LWL
Decision date
2012-03-30
Generic name
Fluid, intraocular
Approval order statement
APPROVAL FOR MINOR LABELING CHANGES TO THE APPROVED SECONDARY LABEL LID AND TO IMPLEMENT AN ALTERNATE SECONDARY PRINTING OPERATION ASSOCIATED WITH THE IMPLEMENTATION OF THESE MINOR LABELING CHANGES.

Current openFDA PMA Record#

Device
PERFLUORON
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S015
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2012-03-30
Decision code
APPR
Date received
2012-01-30
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR MINOR LABELING CHANGES TO THE APPROVED SECONDARY LABEL LID AND TO IMPLEMENT AN ALTERNATE SECONDARY PRINTING OPERATION ASSOCIATED WITH THE IMPLEMENTATION OF THESE MINOR LABELING CHANGES.