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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 IOL
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP960028
Supplement NumberS037
Date Received05/24/2013
Decision Date06/18/2013
Product Code MFK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
NEW TEST METHOD VALIDATION FOR THE ULTRA HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY (UHPLC) SYSTEM.
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