PMA P110014S010

Device
MarginProbe System
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S010
Product code
OEE
Decision date
2019-12-02
Generic name
Diagnostic low electric field
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
MarginProbe System
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S010
Product code
OEE
Generic name
Diagnostic low electric field
Decision date
2019-12-02
Decision code
APPR
Date received
2019-10-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.