Approval for changes to the labeling to reflect the results of the post-approval study.
| Device | HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM |
| Classification Name | Device, Thermal Ablation, Endometrial |
| Generic Name | Device, Thermal Ablation, Endometrial |
| Applicant | CooperSurgical, Inc. |
| Date Received | 2012-08-23 |
| Decision Date | 2013-02-06 |
| PMA | P000032 |
| Supplement | S038 |
| 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 | CooperSurgical, Inc. 95 Corporate Dr. trumbull, CT 06611 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000032 | | Original Filing |
| S043 |
2017-12-12 |
Normal 180 Day Track |
| S042 |
2014-11-24 |
30-day Notice |
| S041 |
2013-06-17 |
30-day Notice |
| S040 |
2013-02-08 |
30-day Notice |
| S039 |
2013-02-08 |
30-day Notice |
| S038 |
2012-08-23 |
Normal 180 Day Track No User Fee |
| S037 |
2011-10-03 |
Normal 180 Day Track No User Fee |
| S036 |
2011-07-25 |
Normal 180 Day Track No User Fee |
| S035 |
2010-01-26 |
30-day Notice |
| S034 |
2010-01-25 |
30-day Notice |
| S033 |
2010-01-22 |
135 Review Track For 30-day Notice |
| S032 |
2010-01-21 |
135 Review Track For 30-day Notice |
| S031 |
2009-12-11 |
30-day Notice |
| S030 |
2009-11-23 |
Real-time Process |
| S029 |
2009-10-02 |
30-day Notice |
| S028 |
2008-06-06 |
Normal 180 Day Track |
| S027 |
2008-04-25 |
30-day Notice |
| S026 |
2008-03-18 |
30-day Notice |
| S025 |
2008-02-06 |
135 Review Track For 30-day Notice |
| S024 |
2008-01-09 |
30-day Notice |
| S023 |
2007-11-27 |
30-day Notice |
| S022 |
2007-10-17 |
135 Review Track For 30-day Notice |
| S021 |
2007-06-28 |
30-day Notice |
| S020 |
2006-05-17 |
135 Review Track For 30-day Notice |
| S019 |
2006-05-12 |
135 Review Track For 30-day Notice |
| S018 |
2006-03-31 |
135 Review Track For 30-day Notice |
| S017 |
2006-01-17 |
Special (immediate Track) |
| S016 |
2006-01-11 |
30-day Notice |
| S015 | | |
| S014 | | |
| S013 |
2005-08-13 |
Normal 180 Day Track |
| S012 |
2005-08-04 |
Real-time Process |
| S011 |
2005-06-09 |
30-day Notice |
| S010 | | |
| S009 |
2005-05-02 |
30-day Notice |
| S008 |
2005-03-31 |
30-day Notice |
| S007 | | |
| S006 |
2005-02-24 |
30-day Notice |
| S005 |
2004-01-20 |
Normal 180 Day Track No User Fee |
| S004 |
2003-12-08 |
Normal 180 Day Track No User Fee |
| S003 |
2003-04-24 |
Normal 180 Day Track No User Fee |
| S002 | | |
| S001 |
2001-08-09 |
Special (immediate Track) |
NIH GUDID Devices