Changes in the method used to monitor the sterilization cycle for the coaptite® injectable implant for soft tissue augmentation.
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 | 2008-06-30 |
Decision Date | 2008-07-24 |
PMA | P040047 |
Supplement | S007 |
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 |
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