Updates to the programmable logic controller (plc) software used for sterilization chamber 3, an update to the vacuum pump system used in chamber 3, and an update to the validation documentation structure used to support the system.
| Device | Hydro Thermablator Endometrial Ablation System |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-04-28 |
| Decision Date | 2017-05-26 |
| PMA | P000040 |
| Supplement | S036 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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