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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceHYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantAxora Medical, Inc.
1 Independent Dr. Suite 2300
Jacksonville, FL 32202
PMA NumberP000040
Date Received09/25/2000
Decision Date04/20/2001
Product Code MNB 
Docket Number 01M-0578
Notice Date 12/21/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S027 S019 S020 S017 S004 S007 S012 S003 S005 S006 S008 
S009 S013 S018 S014 S015 S016 S035 S036 S040 S037 S010 S011 
S025 S033 S024 S026 S034 S031 S021 S022 S023 S029 S028 S001 
S002 S030 S039 S032 S038 S041 S042 
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