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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP880081
Supplement NumberS035
Date Received10/02/2007
Decision Date11/19/2007
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
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