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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.
 
DeviceMarginProbe System
Generic NameDiagnostic low electric field
ApplicantDilon Medical Technologies, Ltd.
20 Alon Hatavor St.
P.O. Box 3131
Business Park-South 3088900 
PMA NumberP110014
Supplement NumberS012
Date Received10/14/2021
Decision Date04/06/2022
Product Code OEE 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02406599
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes including post-approval study clinical data
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