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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.
 
DeviceTECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS051
Date Received10/16/2014
Decision Date11/12/2014
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDING AN ALTERNATE MOLDING SUPPLIER FOR THE CARTRIDGE COMPONENT USED IN THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.
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