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 minerva endometrial ablation system. This device is indicated for ablation of the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
| Device | MINERVA ENDOMETRIAL ABLATION SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | MINERVA SURGICAL |
| Date Received | 2014-07-01 |
| Decision Date | 2015-07-27 |
| Notice Date | 2015-08-27 |
| PMA | P140013 |
| Supplement | S |
| Product Code | MNB |
| Docket Number | 15M-2739 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MINERVA SURGICAL 101 Saginaw Drive redwood City, CA 94063 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00862393000162 | P140013 | 000 |
| 00862393000155 | P140013 | 000 |
| 00862393000131 | P140013 | 000 |
| 00862393000117 | P140013 | 000 |
| 00862393000148 | P140013 | 000 |
| 00862393000148 | P140013 | 012 |
| 00862393000117 | P140013 | 012 |
| 00862393000162 | P140013 | 012 |
| 00862393000100 | P140013 | 012 |
| 00862393000131 | P140013 | 012 |