PMA P960028S025

Device: MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S025
Product code: MFK
Decision date: 2007-11-19
Generic name: Lens, multifocal intraocular
Approval order statement: USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.

Current openFDA PMA Record#

Device: MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S025
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 2007-11-19
Decision code: OK30
Date received: 2007-10-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF AN ADDITIONAL STERILIZATION CHAMBER FOR ETHYLENE OXIDE (EO) STERILIZATION OF IOL?S RESULTING IN BETTER TEMPERATURE DISTRIBUTION, BETTER SPACE UTILIZATION, AND LOWER STERILIZATION COSTS THAN THE CURRENT CHAMBER.