ESSURE SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Premarket Approval P020014 S008

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 a proposed packaging modification and subsequent changes to the ethylene oxide (eo) sterilization cycle and shelf life validation study.

• Device: ESSURE SYSTEM
• Classification Name: Transcervical Contraceptive Tubal Occlusion Device
• Generic Name: Transcervical Contraceptive Tubal Occlusion Device
• Applicant: BAYER PHARMA AG
• Date Received: 2004-09-20
• Decision Date: 2005-01-31
• PMA: P020014
• Supplement: S008
• Product Code: HHS
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Real-time Process
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: BAYER PHARMA AG mollerstrabe 178 berlin 13353

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