PMA P950018S020

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S020
Product code
LWL
Decision date
2021-11-23
Generic name
Fluid, intraocular
Approval order statement
Alternate sterilization cycle on sterilizer 28 to be used in parallel with the current sterilization cycle on Sterilizer 3.

Current openFDA PMA Record#

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S020
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2021-11-23
Decision code
OK30
Date received
2021-10-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate sterilization cycle on sterilizer 28 to be used in parallel with the current sterilization cycle on Sterilizer 3.