This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the marginprobe system. This device is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (
| Device | DUNE MEDICAL DEVICES MARGINPROBE SYSTEM |
| Classification Name | Diagnostic Low Electric Field |
| Generic Name | Diagnostic Low Electric Field |
| Applicant | DUNE MEDICAL DEVICES INC |
| Date Received | 2011-04-04 |
| Decision Date | 2012-12-27 |
| Notice Date | 2012-01-08 |
| PMA | P110014 |
| Supplement | S |
| Product Code | OEE |
| Docket Number | 13M-0036 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | DUNE MEDICAL DEVICES INC 111 Speen St Suite 101 framingham, MA 01701 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 07290012534010 | P110014 | 000 |
| 07290012534034 | P110014 | 000 |
| 07290012534058 | P110014 | 000 |