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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.
 
DeviceOne-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS119
Date Received07/06/2020
Decision Date08/03/2020
Product Code HQL 
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  
Align the flat time test procedure using mainly one (1) representative procedure (QI356) to perform flat time test as opposed to using various procedures for different packaging configurations/delivery systems.
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