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 changes to the gynecare thermachoice iii ubt labels, instructions for use, operating manual, and patient labeling.
| Device | GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | GYNECARE, INC. |
| Date Received | 2015-10-06 |
| Decision Date | 2016-01-04 |
| PMA | P970021 |
| Supplement | S044 |
| Product Code | MNB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |