Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic NameDiagnostic low electric field
ApplicantDilon Medical Technologies, Ltd.
20 Alon Hatavor St.
P.O. Box 3131
Business Park-South 3088900 
PMA NumberP110014
Supplement NumberS013
Date Received01/22/2025
Decision Date09/17/2025
Product Code OEE 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the modification of the MP 2.0 System including MP 2.0 Console and MP 2.a Probe with the use of multiple array technology with multiple sensors.
-
-