MarginProbe System

Diagnostic Low Electric Field

FDA Premarket Approval P110014 S009

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

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p110014

• Device: MarginProbe System
• Classification Name: Diagnostic Low Electric Field
• Generic Name: Diagnostic Low Electric Field
• Applicant: DUNE MEDICAL DEVICES INC
• Date Received: 2019-08-29
• Decision Date: 2019-09-20
• PMA: P110014
• Supplement: S009
• Product Code: OEE
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• 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