PMA P950018S027

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S027
Product code
LWL
Decision date
2023-12-12
Classification
Ophthalmic
Generic name
Fluid, intraocular
Approval order statement
change to utilize new material Zinc, supplied by EMD, to manufacture Perfluoron product

Current openFDA PMA Record#

Device
Perfluoron
Applicant
Alcon Laboratories
PMA number
P950018
Supplement
S027
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2023-12-12
Decision code
OK30
Date received
2023-11-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
change to utilize new material Zinc, supplied by EMD, to manufacture Perfluoron product