PMA P950018S025

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S025
Product code
LWL
Decision date
2023-11-21
Classification
Ophthalmic
Generic name
Fluid, intraocular
Approval order statement
a change to add an alternate sterile, single use needle to the Perfluoron kit packaging

Current openFDA PMA Record#

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S025
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2023-11-21
Decision code
OK30
Date received
2023-10-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to add an alternate sterile, single use needle to the Perfluoron kit packaging