HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P000040

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the hydro thermablator(r) endometrial ablation system. The device is intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom child bearing is complete.

• Device: HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
• Classification Name: Device, Thermal Ablation, Endometrial
• Generic Name: Device, Thermal Ablation, Endometrial
• Applicant: Boston Scientific Corp.
• Date Received: 2000-09-25
• Decision Date: 2001-04-20
• Notice Date: 2001-12-21
• PMA: P000040
• Supplement: S
• Product Code: MNB
• Docket Number: 01M-0578
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review: No
• Combination Product: No
• Applicant Address: Boston Scientific Corp. 100 Boston Scientific Way mb 21 marlborough, MA 01752
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P000040		Original 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 ID	PMA	Supp
08714729809357	P000040	014
08714729809326	P000040	014