Genesys HTA System

FDA Premarket Approval P000040 S042

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

DeviceGenesys HTA System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantMinerva Surgical, Inc.4255 Burton Drivesanta Clara, CA 95054 PMA NumberP000040 Supplement NumberS042 Date Received04/27/2022 Decision Date05/26/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-27
Decision Date2022-05-26
PMAP000040
SupplementS042
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMinerva Surgical, Inc.
4255 Burton Drive
santa Clara, CA 95054 PMA NumberP000040 Supplement NumberS042 Date Received04/27/2022 Decision Date05/26/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Manufacturing Sites Located At Life Science Outsourcing, Inc, 830 Challenger Street, Brea, CA 92821 And Sterilization Services At STERIS Applied Sterilization Technologies, 43425 Business Park Drive, Temecula, CA 92590.

Supplemental Filings

Supplement NumberDateSupplement Type
P000040Original Filing
S042 2022-04-27 Normal 180 Day Track No User Fee
S041 2021-05-20 Normal 180 Day Track No User Fee
S040 2020-12-03 30-day Notice
S039 2020-07-02 30-day Notice
S038 2020-03-12 Normal 180 Day Track No User Fee
S037 2019-08-14 30-day Notice
S036 2017-04-28 30-day Notice
S035 2017-04-11 Normal 180 Day Track No User Fee
S034 2014-10-27 30-day Notice
S033 2014-09-19 30-day Notice
S032 2014-05-14 30-day Notice
S031 2013-11-15 30-day Notice
S030 2013-04-10 Real-time Process
S029 2013-02-22 Normal 180 Day Track No User Fee
S028 2013-02-22 Real-time Process
S027 2012-12-05 Normal 180 Day Track No User Fee
S026 2012-10-17 Real-time Process
S025 2012-09-28 30-day Notice
S024 2012-05-07 Real-time Process
S023 2012-01-31 30-day Notice
S022 2012-01-12 30-day Notice
S021 2011-12-23 Normal 180 Day Track No User Fee
S020 2011-10-03 Normal 180 Day Track
S019 2011-08-31 30-day Notice
S018 2010-09-21 Normal 180 Day Track
S017 2010-07-19 30-day Notice
S016 2010-06-14 30-day Notice
S015 2010-05-24 Normal 180 Day Track No User Fee
S014 2009-05-06 Normal 180 Day Track
S013 2009-02-13 Real-time Process
S012 2007-09-25 Real-time Process
S011 2007-06-12 Special (immediate Track)
S010 2007-03-29 Normal 180 Day Track No User Fee
S009 2006-11-07 Real-time Process
S008 2006-05-15 Real-time Process
S007 2006-02-21 Normal 180 Day Track
S006 2005-07-18 Real-time Process
S005 2005-06-20 Special (immediate Track)
S004 2003-08-25 Normal 180 Day Track No User Fee
S003 2003-01-21 Special (immediate Track)
S002 2001-10-09 Normal 180 Day Track
S001 2001-06-18 Real-time Process

NIH GUDID Devices

Device IDPMASupp
08714729809357 P000040 014
08714729809326 P000040 014

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