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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 SIMPILICITY™ Delivery System, SmartLOAD Delivery Technology
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS170
Date Received12/20/2024
Decision Date01/14/2025
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes in the Directions for Use in the labeling for the intraocular lenses (IOLs) using the TECNIS SIMPILICITY™ Delivery System or the SmartLOAD Delivery Technology to strengthen the warnings and instructions to enhance the safe use of the device
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