PMA P950018S009

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S009
Product code: LWL
Decision date: 2003-03-20
Classification: Fluid, Intraocular
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR A NEW STABILITY PROTOCOL THAT WILL EXTEND THE EXPIRATION DATING FOR PERFLUORON FROM 2 YEARS TO UP TO 4 YEARS FOR THE CURRENTLY APPROVED PRODUCT CONFIGURATION, WITH STABILITY TESTING DATA REPORTED VIA ANNUAL REPORTS IN THE FUTURE.

Current openFDA PMA Record#

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S009
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2003-03-20
Decision code: APPR
Date received: 2003-02-14
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A NEW STABILITY PROTOCOL THAT WILL EXTEND THE EXPIRATION DATING FOR PERFLUORON FROM 2 YEARS TO UP TO 4 YEARS FOR THE CURRENTLY APPROVED PRODUCT CONFIGURATION, WITH STABILITY TESTING DATA REPORTED VIA ANNUAL REPORTS IN THE FUTURE.