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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, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS060
Date Received03/23/2015
Decision Date04/17/2015
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  
ALTERNATIVE MOLDING SUPPLIER FOR THE UPPER BODY COMPONENT OF THE TECNIS® PRELOADED DELIVERY SYSTEMS (MODELS PCB00, PMB00, PCT150, PCT225, PCT300, AND PCT400) AND AN ALTERNATIVE MOLD SUPPLIER FOR THE 1MTEC30 CARTRIDGE, LOWER BODY AND PROTECTOR CAP COMPONENTS.
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