Replace the current manual deploy and detach test fixture with an automated test fixture for lot release testing of he essure system.
| Device | CONCEPTUS ESSURE SYSTEM |
| Generic Name | Transcervical Contraceptive Tubal Occlusion Device |
| Applicant | BAYER PHARMA AG |
| Date Received | 2012-03-05 |
| Decision Date | 2012-05-17 |
| PMA | P020014 |
| Supplement | S037 |
| Product Code | HHS |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER PHARMA AG mollerstrabe 178 berlin 13353 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020014 | | Original Filing |
| S051 |
2018-04-04 |
Special (immediate Track) |
| S050 |
2018-03-01 |
30-day Notice |
| S049 |
2017-11-20 |
30-day Notice |
| S048 |
2016-11-21 |
30-day Notice |
| S047 |
2016-07-29 |
Normal 180 Day Track No User Fee |
| S046 |
2016-05-19 |
Normal 180 Day Track |
| S045 |
2016-02-25 |
Normal 180 Day Track No User Fee |
| S044 |
2015-09-01 |
Normal 180 Day Track No User Fee |
| S043 |
2014-11-24 |
Normal 180 Day Track No User Fee |
| S042 |
2014-07-07 |
Normal 180 Day Track No User Fee |
| S041 |
2014-03-14 |
Normal 180 Day Track |
| S040 |
2013-10-03 |
Special (immediate Track) |
| S039 |
2012-11-19 |
Normal 180 Day Track No User Fee |
| S038 |
2012-04-16 |
Normal 180 Day Track |
| S037 |
2012-03-05 |
30-day Notice |
| S036 |
2011-10-05 |
Normal 180 Day Track No User Fee |
| S035 |
2011-04-14 |
Normal 180 Day Track No User Fee |
| S034 |
2011-04-12 |
|
| S033 |
2011-03-22 |
Normal 180 Day Track |
| S032 |
2010-12-28 |
Real-time Process |
| S031 | | |
| S030 |
2010-01-15 |
30-day Notice |
| S029 |
2009-10-13 |
Normal 180 Day Track No User Fee |
| S028 | | |
| S027 |
2009-05-22 |
Special (immediate Track) |
| S026 |
2009-05-15 |
Normal 180 Day Track No User Fee |
| S025 |
2009-05-11 |
30-day Notice |
| S024 |
2009-01-30 |
135 Review Track For 30-day Notice |
| S023 |
2009-01-09 |
Real-time Process |
| S022 |
2009-01-02 |
Normal 180 Day Track |
| S021 |
2008-09-11 |
Real-time Process |
| S020 |
2008-07-23 |
Real-time Process |
| S019 |
2008-06-30 |
Normal 180 Day Track No User Fee |
| S018 |
2008-05-27 |
Normal 180 Day Track No User Fee |
| S017 |
2008-04-04 |
Normal 180 Day Track |
| S016 | | |
| S015 |
2008-02-04 |
Special (immediate Track) |
| S014 |
2007-06-25 |
Normal 180 Day Track No User Fee |
| S013 |
2006-07-17 |
Special (immediate Track) |
| S012 |
2006-03-17 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2005-11-23 |
Normal 180 Day Track No User Fee |
| S009 |
2005-01-24 |
Normal 180 Day Track No User Fee |
| S008 |
2004-09-20 |
Real-time Process |
| S007 |
2004-03-24 |
Normal 180 Day Track No User Fee |
| S006 |
2003-12-08 |
Normal 180 Day Track |
| S005 |
2003-11-10 |
Normal 180 Day Track No User Fee |
| S004 |
2003-05-21 |
Real-time Process |
| S003 |
2003-03-13 |
Special (immediate Track) |
| S002 |
2003-03-11 |
Real-time Process |
| S001 |
2002-12-23 |
Real-time Process |
NIH GUDID Devices