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.
Approval for updated professional labeling to reflect the results of the post-approval study required as a condition of approval to supplement 14.
| Device | GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | GYNECARE, INC. |
| Date Received | 2009-11-20 |
| Decision Date | 2010-05-13 |
| PMA | P970021 |
| Supplement | S028 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GYNECARE, INC. p.o. Box 151 sommerville, NJ 08876-0151 |
| 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 |