PMA P950018S002

Device: PERFLURON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S002
Product code: LWL
Decision date: 1999-03-05
Classification: Fluid, Intraocular
Generic name: Fluid, intraocular
Approval order statement: Approval for the following changes: use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.

Current openFDA PMA Record#

Device: PERFLURON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S002
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 1999-03-05
Decision code: APPR
Date received: 1999-02-11
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the following changes: use of an alternate Fluorotec S2-F451W stopper; changes in the aseptic filling and packaging processes to use the CBL Autobloc automated filling line; an alternate fill volume (2 ml) for Perfluoron in a unit package; a new Master Batch Record for the automated filling line which includes 2 ml, 5 ml and 7 ml fill volumes and a lot size increase to a maximum of 9,000 vials per lot; secondary packaging configurations designed to provide a vial (5ml or 7ml) in a unit package without other kit components as well as in as accessory kit; and the kit components provided as a stand-alone accessory kit.