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.
| Device | MarginProbe System |
| Generic Name | Diagnostic Low Electric Field |
| Applicant | Dilon Medical Technologies, Ltd.20 Alon Hatavor Streetp.o. Box 3131business Park-south 3088900 PMA NumberP110014 Supplement NumberS012 Date Received10/14/2021 Decision Date04/06/2022 Product Code OEE Advisory Committee General & Plastic Surgery Clinical TrialsNCT02406599 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2021-10-14 |
| Decision Date | 2022-04-06 |
| PMA | P110014 |
| Supplement | S012 |
| Product Code | OEE |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Dilon Medical Technologies, Ltd. 20 Alon Hatavor Street p.o. Box 3131 business Park-south 3088900 PMA NumberP110014 Supplement NumberS012 Date Received10/14/2021 Decision Date04/06/2022 Product Code OEE Advisory Committee General & Plastic Surgery Clinical TrialsNCT02406599 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Labeling Changes Including Post-approval Study Clinical Data |
| 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 |