PMA P950018S026

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S026
Product code
LWL
Decision date
2023-11-28
Classification
Ophthalmic
Generic name
Fluid, intraocular
Approval order statement
approval for the addition of a warning and precaution to the Perfluoron Indications for Use

Current openFDA PMA Record#

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S026
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2023-11-28
Decision code
APPR
Date received
2023-11-03
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
approval for the addition of a warning and precaution to the Perfluoron Indications for Use