ESSURE SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Premarket Approval P020014

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 the essure system. The device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

• Device: ESSURE SYSTEM
• Classification Name: Transcervical Contraceptive Tubal Occlusion Device
• Generic Name: Transcervical Contraceptive Tubal Occlusion Device
• Applicant: BAYER PHARMA AG
• Date Received: 2002-04-22
• Decision Date: 2002-11-04
• Notice Date: 2003-04-28
• PMA: P020014
• Supplement: S
• Product Code: HHS
• Docket Number: 03M-0175
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: BAYER PHARMA AG mollerstrabe 178 berlin 13353
• 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
P020014		Original Filing
S051	2018-04-04	Special (immediate Track)
S050	2018-03-01	30-day Notice
S049	2017-11-20	30-day Notice
S048	2016-11-21	30-day Notice
S047	2016-07-29	Normal 180 Day Track No User Fee
S046	2016-05-19	Normal 180 Day Track
S045	2016-02-25	Normal 180 Day Track No User Fee
S044	2015-09-01	Normal 180 Day Track No User Fee
S043	2014-11-24	Normal 180 Day Track No User Fee
S042	2014-07-07	Normal 180 Day Track No User Fee
S041	2014-03-14	Normal 180 Day Track
S040	2013-10-03	Special (immediate Track)
S039	2012-11-19	Normal 180 Day Track No User Fee
S038	2012-04-16	Normal 180 Day Track
S037	2012-03-05	30-day Notice
S036	2011-10-05	Normal 180 Day Track No User Fee
S035	2011-04-14	Normal 180 Day Track No User Fee
S034	2011-04-12
S033	2011-03-22	Normal 180 Day Track
S032	2010-12-28	Real-time Process
S031
S030	2010-01-15	30-day Notice
S029	2009-10-13	Normal 180 Day Track No User Fee
S028
S027	2009-05-22	Special (immediate Track)
S026	2009-05-15	Normal 180 Day Track No User Fee
S025	2009-05-11	30-day Notice
S024	2009-01-30	135 Review Track For 30-day Notice
S023	2009-01-09	Real-time Process
S022	2009-01-02	Normal 180 Day Track
S021	2008-09-11	Real-time Process
S020	2008-07-23	Real-time Process
S019	2008-06-30	Normal 180 Day Track No User Fee
S018	2008-05-27	Normal 180 Day Track No User Fee
S017	2008-04-04	Normal 180 Day Track
S016
S015	2008-02-04	Special (immediate Track)
S014	2007-06-25	Normal 180 Day Track No User Fee
S013	2006-07-17	Special (immediate Track)
S012	2006-03-17	Normal 180 Day Track
S011
S010	2005-11-23	Normal 180 Day Track No User Fee
S009	2005-01-24	Normal 180 Day Track No User Fee
S008	2004-09-20	Real-time Process
S007	2004-03-24	Normal 180 Day Track No User Fee
S006	2003-12-08	Normal 180 Day Track
S005	2003-11-10	Normal 180 Day Track No User Fee
S004	2003-05-21	Real-time Process
S003	2003-03-13	Special (immediate Track)
S002	2003-03-11	Real-time Process
S001	2002-12-23	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
20888853003058	P020014	012
10888853003051	P020014	012
00888853030517	P020014	012