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Device | MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P960028 |
Supplement Number | S025 |
Date Received | 10/02/2007 |
Decision Date | 11/19/2007 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |