Approval of the following changes to the post-approval study for the device: to increase in number of study sites.
| Device | NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | HOLOGIC, INC. |
| Date Received | 2015-04-16 |
| Decision Date | 2015-06-15 |
| PMA | P010013 |
| Supplement | S063 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010013 | | Original Filing |
| S089 |
2022-11-02 |
Special (immediate Track) |
| S088 |
2022-10-31 |
30-day Notice |
| S087 |
2022-08-03 |
30-day Notice |
| S086 |
2021-11-12 |
30-day Notice |
| S085 | | |
| S084 |
2021-08-30 |
30-day Notice |
| S083 |
2021-03-29 |
30-day Notice |
| S082 | | |
| S081 | | |
| S080 |
2020-10-27 |
30-day Notice |
| S079 |
2020-10-19 |
30-day Notice |
| S078 |
2019-09-30 |
30-day Notice |
| S077 |
2019-09-23 |
30-day Notice |
| S076 | | |
| S075 | | |
| S074 | | |
| S073 |
2019-01-16 |
30-day Notice |
| S072 |
2018-08-23 |
135 Review Track For 30-day Notice |
| S071 |
2018-06-28 |
30-day Notice |
| S070 |
2018-04-19 |
30-day Notice |
| S069 |
2017-12-11 |
30-day Notice |
| S068 |
2017-06-23 |
30-day Notice |
| S067 |
2016-08-01 |
Normal 180 Day Track |
| S066 |
2015-09-17 |
Real-time Process |
| S065 |
2015-08-17 |
Normal 180 Day Track No User Fee |
| S064 |
2015-07-24 |
Normal 180 Day Track No User Fee |
| S063 |
2015-04-16 |
Normal 180 Day Track No User Fee |
| S062 |
2015-02-24 |
30-day Notice |
| S061 |
2014-10-14 |
30-day Notice |
| S060 |
2014-09-11 |
30-day Notice |
| S059 |
2014-08-13 |
30-day Notice |
| S058 |
2014-07-27 |
Normal 180 Day Track |
| S057 |
2014-05-21 |
30-day Notice |
| S056 |
2014-05-06 |
30-day Notice |
| S055 |
2014-04-15 |
30-day Notice |
| S054 |
2014-04-01 |
Normal 180 Day Track No User Fee |
| S053 |
2014-02-25 |
30-day Notice |
| S052 |
2014-02-06 |
30-day Notice |
| S051 |
2013-10-17 |
Normal 180 Day Track |
| S050 |
2013-09-11 |
Normal 180 Day Track No User Fee |
| S049 |
2013-09-11 |
30-day Notice |
| S048 |
2013-08-01 |
30-day Notice |
| S047 |
2013-07-26 |
Normal 180 Day Track |
| S046 |
2013-06-13 |
30-day Notice |
| S045 |
2012-09-19 |
Real-time Process |
| S044 | | |
| S043 |
2012-02-06 |
Real-time Process |
| S042 |
2011-11-08 |
Real-time Process |
| S041 |
2011-09-07 |
Normal 180 Day Track |
| S040 | | |
| S039 |
2011-07-22 |
30-day Notice |
| S038 | | |
| S037 | | |
| S036 |
2011-06-01 |
30-day Notice |
| S035 |
2011-04-13 |
30-day Notice |
| S034 |
2011-03-17 |
30-day Notice |
| S033 |
2010-12-13 |
30-day Notice |
| S032 |
2010-11-19 |
135 Review Track For 30-day Notice |
| S031 |
2010-10-27 |
135 Review Track For 30-day Notice |
| S030 |
2010-06-28 |
30-day Notice |
| S029 |
2010-05-24 |
30-day Notice |
| S028 |
2010-05-04 |
30-day Notice |
| S027 |
2009-12-10 |
30-day Notice |
| S026 |
2009-11-13 |
Real-time Process |
| S025 |
2009-08-17 |
Real-time Process |
| S024 |
2009-06-30 |
Special (immediate Track) |
| S023 |
2009-04-08 |
Special (immediate Track) |
| S022 |
2009-03-23 |
Normal 180 Day Track No User Fee |
| S021 |
2008-12-09 |
Real-time Process |
| S020 |
2008-07-17 |
Normal 180 Day Track No User Fee |
| S019 |
2007-12-13 |
Normal 180 Day Track No User Fee |
| S018 |
2007-02-20 |
Normal 180 Day Track No User Fee |
| S017 |
2006-08-03 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2005-12-13 |
Normal 180 Day Track No User Fee |
| S014 |
2005-05-12 |
Real-time Process |
| S013 | | |
| S012 |
2004-10-25 |
Normal 180 Day Track No User Fee |
| S011 |
2004-09-08 |
Normal 180 Day Track No User Fee |
| S010 |
2004-08-13 |
Special (immediate Track) |
| S009 |
2004-07-09 |
Special (immediate Track) |
| S008 |
2004-07-27 |
Real-time Process |
| S007 |
2003-11-05 |
Special (immediate Track) |
| S006 |
2003-10-09 |
Normal 180 Day Track No User Fee |
| S005 |
2003-04-25 |
Real-time Process |
| S004 |
2002-12-24 |
Real-time Process |
| S003 |
2002-08-28 |
Normal 180 Day Track |
| S002 |
2002-05-08 |
30-day Notice |
| S001 |
2002-01-22 |
Normal 180 Day Track |
NIH GUDID Devices