PMA P950018S021

Device
Perfluoron™
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S021
Product code
LWL
Decision date
2022-08-12
Generic name
Fluid, intraocular
Approval order statement
Adding an alternate supplier of potassium hydroxide.

Current openFDA PMA Record#

Device
Perfluoron™
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S021
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2022-08-12
Decision code
OK30
Date received
2022-07-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding an alternate supplier of potassium hydroxide.