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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation system
ApplicantETHICON WOMEN'S HEALTH & UROLOGY
PMA NumberP970021
Supplement NumberS014
Date Received01/11/2007
Decision Date07/06/2007
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised professional labeling to include the results of a multi-center study of the gynecare thermachoice iii uterine balloon therapy (ubt) system.
Post-Approval StudyShow Report Schedule and Study Progress
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