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 | NovaSure Impedance Controlled Endometrial Ablation System |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS089 Date Received11/02/2022 Decision Date12/01/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-11-02 |
| Decision Date | 2022-12-01 |
| PMA | P010013 |
| Supplement | S089 |
| 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 | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752 PMA NumberP010013 Supplement NumberS089 Date Received11/02/2022 Decision Date12/01/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Inclusion Of Updated Language To A Contraindication In The Device Instructions For Use. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 25420045505398 | P010013 | 000 |
| 15420045500860 | P010013 | 000 |
| 15420045515154 | P010013 | 000 |
| 15420045514294 | P010013 | 000 |
| 15420045514300 | P010013 | 000 |
| 25420045514307 | P010013 | 000 |
| 15420045501133 | P010013 | 026 |
| 15420045501140 | P010013 | 026 |
| 15420045500860 | P010013 | 051 |
| 15420045501140 | P010013 | 055 |
| 15420045501133 | P010013 | 055 |
| 15420045501126 | P010013 | 055 |
| 15420045501119 | P010013 | 055 |
| 15420045500860 | P010013 | 055 |
| 15420045500853 | P010013 | 055 |
| 15420045514300 | P010013 | 081 |
| 15420045514294 | P010013 | 081 |