NovaSure Impedance Controlled Endometrial Ablation System

FDA Premarket Approval P010013 S083

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

Consolidation of inspection test steps to reduce any over-manipulation of the devices in the manufacturing process and modification of the current inspection sampling method for the array liner and array sewing assembly of the novasure gen 4. 1 devices from a defined sampling size to a credit sampling method

DeviceNovaSure Impedance Controlled Endometrial Ablation System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantHOLOGIC, INC.
Date Received2021-03-29
Decision Date2021-03-30
PMAP010013
SupplementS083
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
S083 2021-03-29 30-day Notice
S082
S081
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
15420045501140 P010013 055
15420045501133 P010013 055
15420045501126 P010013 055
15420045501119 P010013 055
15420045500860 P010013 055
15420045500853 P010013 055

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