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 a material change to the silixone balloon. The device, as modified, will be marketed under the trade name gynecare thermachoice iii uterine balloon therapy system.
| Device | THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM |
| Classification Name | Catheter, Balloon, Transcervical |
| Generic Name | Catheter, Balloon, Transcervical |
| Applicant | GYNECARE, INC. |
| Date Received | 2002-11-08 |
| Decision Date | 2003-05-07 |
| PMA | P970021 |
| Supplement | S006 |
| Product Code | MKN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |