CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Transcervical Contraceptive Tubal Occlusion Device

FDA Premarket Approval P020014 S035

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 revised professional and patient labeling.

DeviceCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Classification NameTranscervical Contraceptive Tubal Occlusion Device
Generic NameTranscervical Contraceptive Tubal Occlusion Device
ApplicantBAYER PHARMA AG
Date Received2011-04-14
Decision Date2012-03-19
PMAP020014
SupplementS035
Product CodeHHS
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BAYER PHARMA AG mollerstrabe 178 berlin 13353

Supplemental Filings

Supplement NumberDateSupplement Type
P020014Original 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 IDPMASupp
20888853003058 P020014 012
10888853003051 P020014 012
00888853030517 P020014 012

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