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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.
 
DeviceJJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS151
Date Received09/28/2022
Decision Date10/27/2022
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  
Change to the location to perform the repackaging activity of Trimethoxysilane Polyethylene Glycol (mPEG) and its receiving testing in Puerto Rico facility.
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