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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.
 
DeviceSENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOL
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS045
Date Received05/24/2013
Decision Date06/18/2013
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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