PMA P110014S001

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S001
Product code
OEE
Decision date
2014-04-29
Classification
Diagnostic Low Electric Field
Generic name
Diagnostic low electric field
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S001
Product code
OEE
Generic name
Diagnostic low electric field
Decision date
2014-04-29
Decision code
APPR
Date received
2013-01-25
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.