Approval for the inclusion of additional warnings and precautions to minimize burn injuries and to ensure proper handling of the procedure sheath.
| Device | HTA SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Boston Scientific Corp. |
| Date Received | 2007-06-12 |
| Decision Date | 2007-07-16 |
| PMA | P000040 |
| Supplement | S011 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 100 Boston Scientific Way mb 21 marlborough, MA 01752 |
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