PMA P110014

Device
MarginProbe
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S012
Product code
OEE
Decision date
2025-09-17
Generic name
Diagnostic low electric field
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.

Current openFDA PMA Record#

Device
MarginProbe
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S013
Product code
OEE
Generic name
Diagnostic low electric field
Decision date
2025-09-17
Decision code
APPR
Date received
2025-01-22
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.