Approval for a manufacturing site change to your new facility located at minerva surgical, 4255 burton drive, santa clara, california. the facility operations at this site involve the manufacturing of the minerva endometrial ablation system disposable handpiece.
| Device | Minerva Endometrial Ablation System |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | MINERVA SURGICAL |
| Date Received | 2020-01-13 |
| Decision Date | 2020-02-12 |
| PMA | P140013 |
| Supplement | S011 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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