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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.
 
DeviceLumicell Direct Visualization System (DVS)
Generic NameFluorescence imaging for breast cancer detection
ApplicantLumicell, Inc.
275 Washington St., Suite 200
Newton, MA 02458
PMA NumberP230014
Supplement NumberS001
Date Received04/29/2024
Decision Date05/29/2024
Product Code SAW 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to the Lumicell Direct Visualization System (DVS), consisting of a supplier change for the mirrors and lenses of the device and the implementation of a manufacturing fixture at the finished device manufacturer to facilitate the gluing procedure for the device
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