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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 NumberS008
Date Received05/21/2019
Decision Date06/19/2019
Product Code OEE 
Advisory Committee General & Plastic Surgery
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  
New sterilization chamber (No. 8) that has been installed and validated at the Company’s approved contract sterilizer, Mediplast Isreal, Ltd. (Tel Aviv Israel, FDA Registration Number 3008729892).
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