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 Implant |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS066 Date Received11/01/2022 Decision Date11/22/2022 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 | 2022-11-22 |
| PMA | P040047 |
| Supplement | S066 |
| 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 NumberS066 Date Received11/01/2022 Decision Date11/22/2022 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 To Reduce The Frequency Of Air Particle Sampling From The Current Three (3) Times Per Month To One (1) Time Per Month In The Merz Site 125 Cleanroom (Sturtevant, WI). |
| 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 |