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 | P040047 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 NumberS069 Date Received12/15/2022 Decision Date01/12/2023 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 | 2022-12-15 |
Decision Date | 2023-01-12 |
PMA | P040047 |
Supplement | S069 |
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 NumberS069 Date Received12/15/2022 Decision Date01/12/2023 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 a Change To The Manufacturing Equipment Cleaning Procedure |
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 |