This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the thermachoice(tm) uterine balloon therapy(tm) ubt system. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.
| Device | THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | GYNECARE, INC. |
| Date Received | 1997-06-17 |
| Decision Date | 1997-12-12 |
| Notice Date | 1998-03-04 |
| PMA | P970021 |
| Supplement | S |
| Product Code | MNB |
| Docket Number | 98M-0139 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GYNECARE, INC. p.o. Box 151 sommerville, NJ 08876-0151 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970021 | Original Filing | |
| S044 | 2015-10-06 | Real-time Process |
| S043 | 2015-09-02 | 30-day Notice |
| S042 | 2014-11-05 | 30-day Notice |
| S041 | 2014-03-07 | Normal 180 Day Track No User Fee |
| S040 | 2013-12-18 | Real-time Process |
| S039 | 2013-12-09 | Normal 180 Day Track No User Fee |
| S038 | 2013-04-24 | Real-time Process |
| S037 | 2012-02-23 | 135 Review Track For 30-day Notice |
| S036 | 2011-08-03 | Real-time Process |
| S035 | 2011-04-08 | 30-day Notice |
| S034 | 2011-03-07 | 30-day Notice |
| S033 | 2011-01-31 | 30-day Notice |
| S032 | 2011-01-20 | 30-day Notice |
| S031 | 2010-10-28 | 30-day Notice |
| S030 | 2010-10-25 | 135 Review Track For 30-day Notice |
| S029 | 2010-08-06 | 135 Review Track For 30-day Notice |
| S028 | 2009-11-20 | Normal 180 Day Track No User Fee |
| S027 | 2009-05-21 | 30-day Notice |
| S026 | 2009-03-06 | Real-time Process |
| S025 | 2008-12-16 | Real-time Process |
| S024 | 2008-12-15 | 30-day Notice |
| S023 | 2008-08-21 | 30-day Notice |
| S022 | 2008-07-25 | 30-day Notice |
| S021 | 2008-07-23 | 30-day Notice |
| S020 | 2008-04-14 | 30-day Notice |
| S019 | 2008-04-14 | Real-time Process |
| S018 | 2008-04-14 | 30-day Notice |
| S017 | ||
| S016 | 2007-12-03 | Normal 180 Day Track No User Fee |
| S015 | 2007-07-13 | Real-time Process |
| S014 | 2007-01-11 | Normal 180 Day Track |
| S013 | ||
| S012 | 2004-12-17 | Special (immediate Track) |
| S011 | 2004-07-07 | Real-time Process |
| S010 | 2003-11-18 | Normal 180 Day Track No User Fee |
| S009 | 2003-06-20 | Normal 180 Day Track |
| S008 | 2003-01-15 | Normal 180 Day Track |
| S007 | 2003-01-13 | Normal 180 Day Track |
| S006 | 2002-11-08 | Normal 180 Day Track |
| S005 | 2000-08-28 | Normal 180 Day Track |
| S004 | 2000-08-07 | Normal 180 Day Track |
| S003 | 2000-03-28 | Normal 180 Day Track |
| S002 | 1999-02-03 | Normal 180 Day Track |
| S001 | 1998-02-02 | Normal 180 Day Track |