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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.
 
DeviceREZOOM MULTIFOCAL ACRYLIC IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP960028
Supplement NumberS030
Date Received08/29/2008
Decision Date09/30/2008
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE SHEET CASTING PROCESS FOR MANUFACTURING THE DEVICE.
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