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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.
 
DeviceThe SENSAR/TECNIS 1-Piece IOL with SmartLOAD Delivery Technology and The TECNIS OptiBlue 1-Piece IOL with SmartLOAD Deli
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS095
Date Received12/03/2018
Decision Date09/13/2019
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional packaging configuration for SENSAR®, TECNIS® and TECNIS® OptiBlue one-piece IOLs into the new SmartLOAD Delivery Technology
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