COAPTITE

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P040047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for coaptite. The device is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd) in adult females.

• Device: COAPTITE
• 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: 2004-12-09
• Decision Date: 2005-11-10
• Notice Date: 2005-11-28
• PMA: P040047
• Supplement: S
• Product Code: LNM
• Docket Number: 05M-0477
• Advisory Committee: Gastroenterology/Urology
• Expedited Review: No
• Combination Product: No
• Applicant Address: MERZ NORTH AMERICA, INC 4133 Courtney Road suite 10 franksville, WI 53126
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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

Device ID	PMA	Supp
08714729804796	P040047	000