Software (seal test station production software) used in the production of the margin probe component of the system was updated to alter the sequence in which a folder name is assigned to an electronic folder containing data from the seal test.
| 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 | 2016-03-07 |
| Decision Date | 2016-03-30 |
| PMA | P110014 |
| Supplement | S007 |
| 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