Approval for the co-packaging of the minerva cervical dilator with the minerva disposable handpiece, modifications to the packaging design to accommodate said co-packaging, and the addition of a manufacturing supplier for the thermoformed tray and insert used in packaging said co-packaged devices.
| Device | Minerva Endometrial Ablation System |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | MINERVA SURGICAL |
| Date Received | 2018-01-31 |
| Decision Date | 2018-05-01 |
| PMA | P140013 |
| Supplement | S009 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MINERVA SURGICAL 101 Saginaw Drive redwood City, CA 94063 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140013 | | Original Filing |
| S013 |
2021-12-23 |
30-day Notice |
| S012 |
2020-11-25 |
Real-time Process |
| S011 |
2020-01-13 |
Normal 180 Day Track No User Fee |
| S010 |
2018-04-09 |
Real-time Process |
| S009 |
2018-01-31 |
Real-time Process |
| S008 | | |
| S007 |
2017-04-03 |
Real-time Process |
| S006 |
2017-02-07 |
Normal 180 Day Track No User Fee |
| S005 |
2016-10-04 |
Normal 180 Day Track |
| S004 |
2016-09-20 |
Normal 180 Day Track No User Fee |
| S003 |
2016-07-05 |
Real-time Process |
| S002 |
2016-04-08 |
Normal 180 Day Track No User Fee |
| S001 |
2015-12-28 |
Real-time Process |
NIH GUDID Devices