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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 NameTHERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE, INC.
PMA NumberP970021
Supplement NumberS001
Date Received02/02/1998
Decision Date03/06/1998
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing site located at seamed corporation, 21621 30th ave. , ne, bothell, wa 98021.
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