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.
| Device | COAPTITE Injectable Impant |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS067 Date Received11/01/2022 Decision Date11/30/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-01 |
| Decision Date | 2022-11-30 |
| PMA | P040047 |
| Supplement | S067 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 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 PMA NumberP040047 Supplement NumberS067 Date Received11/01/2022 Decision Date11/30/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of A Modular Ancillary Cleanroom For Device Manufacturing |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729804796 | P040047 | 000 |