GENESYS HTA SYSTEM

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P000040 S015

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 of the post-approval study protocol.

DeviceGENESYS HTA SYSTEM
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantBoston Scientific Corp.
Date Received2010-05-24
Decision Date2010-07-16
PMAP000040
SupplementS015
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 100 Boston Scientific Way mb 21 marlborough, MA 01752

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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