Approval for a manufacturing site change to your new facility located at apical instruments, inc, 2971 spring street, redwood city, ca 94063. The facility operations at this site will involve the manufacturing of the minerva genesys hta controller.
| Device | Minerva Genesys HTA Endometrial Ablation System |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Minerva Surgical, Inc. |
| Date Received | 2021-05-20 |
| Decision Date | 2021-06-17 |
| PMA | P000040 |
| Supplement | S041 |
| 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, Inc. 4255 Burton Drive santa Clara, CA 95054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000040 | | Original Filing |
| S042 |
2022-04-27 |
Normal 180 Day Track No User Fee |
| S041 |
2021-05-20 |
Normal 180 Day Track No User Fee |
| S040 |
2020-12-03 |
30-day Notice |
| S039 |
2020-07-02 |
30-day Notice |
| S038 |
2020-03-12 |
Normal 180 Day Track No User Fee |
| S037 |
2019-08-14 |
30-day Notice |
| S036 |
2017-04-28 |
30-day Notice |
| S035 |
2017-04-11 |
Normal 180 Day Track No User Fee |
| S034 |
2014-10-27 |
30-day Notice |
| S033 |
2014-09-19 |
30-day Notice |
| S032 |
2014-05-14 |
30-day Notice |
| S031 |
2013-11-15 |
30-day Notice |
| S030 |
2013-04-10 |
Real-time Process |
| S029 |
2013-02-22 |
Normal 180 Day Track No User Fee |
| S028 |
2013-02-22 |
Real-time Process |
| S027 |
2012-12-05 |
Normal 180 Day Track No User Fee |
| S026 |
2012-10-17 |
Real-time Process |
| S025 |
2012-09-28 |
30-day Notice |
| S024 |
2012-05-07 |
Real-time Process |
| S023 |
2012-01-31 |
30-day Notice |
| S022 |
2012-01-12 |
30-day Notice |
| S021 |
2011-12-23 |
Normal 180 Day Track No User Fee |
| S020 |
2011-10-03 |
Normal 180 Day Track |
| S019 |
2011-08-31 |
30-day Notice |
| S018 |
2010-09-21 |
Normal 180 Day Track |
| S017 |
2010-07-19 |
30-day Notice |
| S016 |
2010-06-14 |
30-day Notice |
| S015 |
2010-05-24 |
Normal 180 Day Track No User Fee |
| S014 |
2009-05-06 |
Normal 180 Day Track |
| S013 |
2009-02-13 |
Real-time Process |
| S012 |
2007-09-25 |
Real-time Process |
| S011 |
2007-06-12 |
Special (immediate Track) |
| S010 |
2007-03-29 |
Normal 180 Day Track No User Fee |
| S009 |
2006-11-07 |
Real-time Process |
| S008 |
2006-05-15 |
Real-time Process |
| S007 |
2006-02-21 |
Normal 180 Day Track |
| S006 |
2005-07-18 |
Real-time Process |
| S005 |
2005-06-20 |
Special (immediate Track) |
| S004 |
2003-08-25 |
Normal 180 Day Track No User Fee |
| S003 |
2003-01-21 |
Special (immediate Track) |
| S002 |
2001-10-09 |
Normal 180 Day Track |
| S001 |
2001-06-18 |
Real-time Process |
NIH GUDID Devices