This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Genesys HTA System |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Minerva Surgical, Inc.4255 Burton Drivesanta Clara, CA 95054 PMA NumberP000040 Supplement NumberS042 Date Received04/27/2022 Decision Date05/26/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-05-26 |
| PMA | P000040 |
| Supplement | S042 |
| 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 PMA NumberP000040 Supplement NumberS042 Date Received04/27/2022 Decision Date05/26/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Manufacturing Sites Located At Life Science Outsourcing, Inc, 830 Challenger Street, Brea, CA 92821 And Sterilization Services At STERIS Applied Sterilization Technologies, 43425 Business Park Drive, Temecula, CA 92590. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729809357 | P000040 | 014 |
| 08714729809326 | P000040 | 014 |