Coaptite lnjectable lmplant

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P040047 S055

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.

Pre-market Approval Supplement Details

Approval for modifications to the manufacturing equipment for coaptite injectable implant, radiesse injectable implant, and radiesse (+) lidocaine dermal filler.

DeviceCoaptite lnjectable lmplant
Classification NameAgent, Bulking, Injectable For Gastro-urology Use
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantMERZ NORTH AMERICA, INC
Date Received2019-05-16
Decision Date2019-11-06
PMAP040047
SupplementS055
Product CodeLNM
Advisory CommitteeGastroenterology/Urology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126

Supplemental Filings

Supplement NumberDateSupplement Type
P040047Original Filing
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

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