ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

FDA Premarket Approval P020014 S041

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 changing the essure instructions for use to replace the previously approved modified hysterosalpingogram confirmation test with the transvaginal ultrasound/ hysterosalpingogram confirmation test algorith

DeviceESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Generic NameTranscervical Contraceptive Tubal Occlusion Device
ApplicantBAYER PHARMA AG
Date Received2014-03-14
Decision Date2015-06-29
PMAP020014
SupplementS041
Product CodeHHS 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
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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