MarginProbe System

Diagnostic Low Electric Field

FDA Premarket Approval P110014 S008

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.

Pre-market Approval Supplement Details

A new sterilization chamber (no. 8) that has been installed and validated at the company’s approved contract sterilizer, mediplast isreal, ltd. (tel aviv israel, fda registration number 3008729892)

• Device: MarginProbe System
• Classification Name: Diagnostic Low Electric Field
• Generic Name: Diagnostic Low Electric Field
• Applicant: DUNE MEDICAL DEVICES INC
• Date Received: 2019-05-21
• Decision Date: 2019-06-19
• PMA: P110014
• Supplement: S008
• Product Code: OEE
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: DUNE MEDICAL DEVICES INC 111 Speen St Suite 101 framingham, MA 01701

Supplemental Filings

Supplement Number	Date	Supplement Type
P110014		Original Filing
S012	2021-10-14	Normal 180 Day Track No User Fee
S011	2020-07-28	30-day Notice
S010	2019-10-07	Normal 180 Day Track No User Fee
S009	2019-08-29	Normal 180 Day Track No User Fee
S008	2019-05-21	30-day Notice
S007	2016-03-07	30-day Notice
S006	2015-07-06	Real-time Process
S005	2015-04-15	30-day Notice
S004	2014-09-23	30-day Notice
S003	2014-04-15	Normal 180 Day Track
S002	2014-01-28	Normal 180 Day Track No User Fee
S001	2013-01-25	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
07290012534010	P110014	000
07290012534034	P110014	000
07290012534058	P110014	000