PMA P950018S008

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S008
Product code: LWL
Decision date: 2002-07-29
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR. ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.

Current openFDA PMA Record#

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S008
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2002-07-29
Decision code: APPR
Date received: 2001-12-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR. ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.