PMA P950018S011

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S011
Product code: LWL
Decision date: 2013-08-14
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR A MODIFIED STABILITY PROTOCOL, A CHANGE IN THE PACKAGING TO AN ALTERNATE ALUMINUM SEAL WITH A FLIP-OFF CAP, AND THE ADDITION OF A PRE-PROCESSING MODIFICATION TO SILICONIZE THE STOPPERS USED IN THE FILLING, STOPPING, AND SEALING OF PERFLUORON..

Current openFDA PMA Record#

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S011
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2013-08-14
Decision code: APPR
Date received: 2009-07-14
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MODIFIED STABILITY PROTOCOL, A CHANGE IN THE PACKAGING TO AN ALTERNATE ALUMINUM SEAL WITH A FLIP-OFF CAP, AND THE ADDITION OF A PRE-PROCESSING MODIFICATION TO SILICONIZE THE STOPPERS USED IN THE FILLING, STOPPING, AND SEALING OF PERFLUORON..