• 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 SYSTEM
Generic NameDiagnostic low electric field
ApplicantDilon Medical Technologies, Ltd.
20 Alon Hatavor Street
P.O. Box 3131
Business Park-South 3088900 
PMA NumberP110014
Supplement NumberS004
Date Received09/23/2014
Decision Date10/22/2014
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
Approval Order Statement  
ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT.
-
-