Devices · Dilon Medical Technologies, Ltd.

DUNE MEDICAL DEVICES MARGINPROBE SYSTEM

PMAP110014General and Plastic SurgeryOEE

Dilon Medical Technologies, Ltd. is listed for DUNE MEDICAL DEVICES MARGINPROBE SYSTEM (P110014). The FDA list gives December 27, 2012 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the PMA pathway. openFDA describes product code OEE as “Diagnostic Low Electric Field”: As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation. openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110014

Official FDA database record

Date of final decision: December 27, 2012
Company on the FDA list: Dilon Medical Technologies, Ltd.
Lead panel: General and Plastic Surgery
Primary product code: OEE
openFDA device name for the code: Diagnostic Low Electric Field
Device class: 3
Regulation number: Not returned
openFDA decision description: Not returned
openFDA decision code: APPR
Statement or summary label: Statement

Product-code text from openFDA

As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.