Approval for the implementation of an additional heat sealer with optimized parameters.
| Device | COAPTITE injectable implant |
| Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | MERZ NORTH AMERICA, INC |
| Date Received | 2016-12-06 |
| Decision Date | 2017-06-13 |
| PMA | P040047 |
| Supplement | S044 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040047 | | Original Filing |
| S069 |
2022-12-15 |
30-day Notice |
| S068 |
2022-12-09 |
30-day Notice |
| S067 |
2022-11-01 |
30-day Notice |
| S066 |
2022-11-01 |
30-day Notice |
| S065 | | |
| S064 | | |
| S063 |
2020-09-25 |
30-day Notice |
| S062 |
2020-09-18 |
30-day Notice |
| S061 |
2020-09-18 |
30-day Notice |
| S060 | | |
| S059 | | |
| S058 |
2020-04-21 |
30-day Notice |
| S057 |
2020-04-03 |
30-day Notice |
| S056 | | |
| S055 |
2019-05-16 |
135 Review Track For 30-day Notice |
| S054 |
2019-05-10 |
30-day Notice |
| S053 |
2019-05-09 |
30-day Notice |
| S052 |
2019-01-07 |
Normal 180 Day Track No User Fee |
| S051 |
2018-04-30 |
30-day Notice |
| S050 | | |
| S049 |
2018-01-16 |
30-day Notice |
| S048 | | |
| S047 |
2017-10-19 |
30-day Notice |
| S046 |
2017-10-12 |
Normal 180 Day Track No User Fee |
| S045 |
2017-06-01 |
30-day Notice |
| S044 |
2016-12-06 |
135 Review Track For 30-day Notice |
| S043 |
2016-05-31 |
30-day Notice |
| S042 |
2015-09-04 |
30-day Notice |
| S041 |
2015-06-26 |
30-day Notice |
| S040 |
2015-05-01 |
135 Review Track For 30-day Notice |
| S039 |
2015-04-02 |
30-day Notice |
| S038 |
2015-03-27 |
135 Review Track For 30-day Notice |
| S037 |
2014-10-06 |
30-day Notice |
| S036 |
2014-06-17 |
30-day Notice |
| S035 |
2014-05-23 |
30-day Notice |
| S034 |
2014-02-25 |
30-day Notice |
| S033 |
2014-01-09 |
30-day Notice |
| S032 |
2013-11-25 |
30-day Notice |
| S031 |
2013-11-20 |
30-day Notice |
| S030 |
2013-10-31 |
30-day Notice |
| S029 |
2013-09-27 |
30-day Notice |
| S028 |
2013-09-25 |
30-day Notice |
| S027 |
2013-06-21 |
30-day Notice |
| S026 |
2013-05-08 |
30-day Notice |
| S025 |
2013-02-04 |
30-day Notice |
| S024 |
2012-09-20 |
30-day Notice |
| S023 | | |
| S022 | | |
| S021 |
2011-07-25 |
135 Review Track For 30-day Notice |
| S020 |
2011-06-08 |
30-day Notice |
| S019 |
2011-01-12 |
Normal 180 Day Track No User Fee |
| S018 |
2011-01-11 |
Normal 180 Day Track No User Fee |
| S017 |
2010-05-17 |
30-day Notice |
| S016 |
2010-02-12 |
30-day Notice |
| S015 |
2009-10-06 |
30-day Notice |
| S014 |
2009-02-06 |
30-day Notice |
| S013 |
2009-02-05 |
135 Review Track For 30-day Notice |
| S012 |
2008-12-08 |
30-day Notice |
| S011 |
2008-11-06 |
135 Review Track For 30-day Notice |
| S010 |
2008-10-21 |
135 Review Track For 30-day Notice |
| S009 |
2008-10-16 |
30-day Notice |
| S008 |
2008-08-04 |
30-day Notice |
| S007 |
2008-06-30 |
30-day Notice |
| S006 |
2008-06-30 |
30-day Notice |
| S005 | | |
| S004 |
2007-11-20 |
135 Review Track For 30-day Notice |
| S003 |
2007-05-24 |
30-day Notice |
| S002 |
2007-04-18 |
30-day Notice |
| S001 |
2005-12-09 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices