PMA P950018S028

Device: Perfluoron
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S028
Product code: LWL
Decision date: 2024-06-11
Classification: Ophthalmic
Generic name: Fluid, intraocular
Approval order statement: change to the endotoxin test from Limulus Amebocyte Lysate (LAL) gel-clot method to Kinetic Turbidimetric (KT)/Chromogenic method and the respective releasing specification of the finished Perfluoron product

Current openFDA PMA Record#

Device: Perfluoron
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S028
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2024-06-11
Decision code: OK30
Date received: 2024-05-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change to the endotoxin test from Limulus Amebocyte Lysate (LAL) gel-clot method to Kinetic Turbidimetric (KT)/Chromogenic method and the respective releasing specification of the finished Perfluoron product