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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE, INC.
PMA NumberP970021
Date Received06/17/1997
Decision Date12/12/1997
Product Code
MNB[ Registered Establishments with MNB ]
Docket Number 98M-0139
Notice Date 03/04/1998
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
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.
Post-Approval StudyShow Report Schedule and Study Progress
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 
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