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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.
 
DeviceTHERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGYNECARE, INC.
P.O. BOX 151
SOMMERVILLE, NJ 08876-0151
PMA NumberP970021
Date Received06/17/1997
Decision Date12/12/1997
Withdrawal Date 10/25/2016
Product Code MNB 
Docket Number 98M-0139
Notice Date 03/04/1998
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the ThermaChoice(TM) Uterine Balloon Therapy(TM) UBT System. This device is indicated for the treatment of menorrhagia (excessive uterine bleeding) due to benign causes in premenopausal women for whom child bearing is complete.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 S044 
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