Hydro Thermablator Endometrial Ablation

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P000040 S037

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

To update the software and utilities for sterilization preconditioning and aeration at the bsc coventry, rhode island facility

DeviceHydro Thermablator Endometrial Ablation
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantBoston Scientific Corp.
Date Received2019-08-14
Decision Date2019-09-13
PMAP000040
SupplementS037
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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