Approval for the ¿next generation¿ hta system with a redesigned operational unit (control unit, power cord, pedestal, iv pole) and a modified sterile procedure set. The device, as modified, will be marketed under the trade name genesys hta system and is indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
| Device | GENESYS HTA SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Boston Scientific Corp. |
| Date Received | 2009-05-06 |
| Decision Date | 2010-04-23 |
| PMA | P000040 |
| Supplement | S014 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 100 Boston Scientific Way mb 21 marlborough, MA 01752 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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