NovaSure Impedance Controlled Endometrial Ablation System

FDA Premarket Approval P010013 S080

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

A change in supplier of the cervical seal components of the novosure gen 3 disposable device

DeviceNovaSure Impedance Controlled Endometrial Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantHOLOGIC, INC.
Date Received2020-10-27
Decision Date2020-10-27
PMAP010013
SupplementS080
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P010013Original Filing
S080 2020-10-27 30-day Notice
S079 2020-10-19 30-day Notice
S078 2019-09-30 30-day Notice
S077 2019-09-23 30-day Notice
S076
S075
S074
S073 2019-01-16 30-day Notice
S072 2018-08-23 135 Review Track For 30-day Notice
S071 2018-06-28 30-day Notice
S070 2018-04-19 30-day Notice
S069 2017-12-11 30-day Notice
S068 2017-06-23 30-day Notice
S067 2016-08-01 Normal 180 Day Track
S066 2015-09-17 Real-time Process
S065 2015-08-17 Normal 180 Day Track No User Fee
S064 2015-07-24 Normal 180 Day Track No User Fee
S063 2015-04-16 Normal 180 Day Track No User Fee
S062 2015-02-24 30-day Notice
S061 2014-10-14 30-day Notice
S060 2014-09-11 30-day Notice
S059 2014-08-13 30-day Notice
S058 2014-07-27 Normal 180 Day Track
S057 2014-05-21 30-day Notice
S056 2014-05-06 30-day Notice
S055 2014-04-15 30-day Notice
S054 2014-04-01 Normal 180 Day Track No User Fee
S053 2014-02-25 30-day Notice
S052 2014-02-06 30-day Notice
S051 2013-10-17 Normal 180 Day Track
S050 2013-09-11 Normal 180 Day Track No User Fee
S049 2013-09-11 30-day Notice
S048 2013-08-01 30-day Notice
S047 2013-07-26 Normal 180 Day Track
S046 2013-06-13 30-day Notice
S045 2012-09-19 Real-time Process
S044
S043 2012-02-06 Real-time Process
S042 2011-11-08 Real-time Process
S041 2011-09-07 Normal 180 Day Track
S040
S039 2011-07-22 30-day Notice
S038
S037
S036 2011-06-01 30-day Notice
S035 2011-04-13 30-day Notice
S034 2011-03-17 30-day Notice
S033 2010-12-13 30-day Notice
S032 2010-11-19 135 Review Track For 30-day Notice
S031 2010-10-27 135 Review Track For 30-day Notice
S030 2010-06-28 30-day Notice
S029 2010-05-24 30-day Notice
S028 2010-05-04 30-day Notice
S027 2009-12-10 30-day Notice
S026 2009-11-13 Real-time Process
S025 2009-08-17 Real-time Process
S024 2009-06-30 Special (immediate Track)
S023 2009-04-08 Special (immediate Track)
S022 2009-03-23 Normal 180 Day Track No User Fee
S021 2008-12-09 Real-time Process
S020 2008-07-17 Normal 180 Day Track No User Fee
S019 2007-12-13 Normal 180 Day Track No User Fee
S018 2007-02-20 Normal 180 Day Track No User Fee
S017 2006-08-03 135 Review Track For 30-day Notice
S016
S015 2005-12-13 Normal 180 Day Track No User Fee
S014 2005-05-12 Real-time Process
S013
S012 2004-10-25 Normal 180 Day Track No User Fee
S011 2004-09-08 Normal 180 Day Track No User Fee
S010 2004-08-13 Special (immediate Track)
S009 2004-07-09 Special (immediate Track)
S008 2004-07-27 Real-time Process
S007 2003-11-05 Special (immediate Track)
S006 2003-10-09 Normal 180 Day Track No User Fee
S005 2003-04-25 Real-time Process
S004 2002-12-24 Real-time Process
S003 2002-08-28 Normal 180 Day Track
S002 2002-05-08 30-day Notice
S001 2002-01-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
25420045505398 P010013 000
25420045505398 P010013 000
15420045501133 P010013 055
15420045500860 P010013 055
15420045501119 P010013 055
15420045501126 P010013 055
15420045501133 P010013 055
15420045501140 P010013 055
15420045501140 P010013 055
15420045500853 P010013 055
15420045500860 P010013 055
15420045501119 P010013 055
15420045501126 P010013 055
15420045500853 P010013 055

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