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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 III UTERINE BALLOON THERAPY SYSTEM
Classification Namecatheter, balloon, transcervical
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE
PMA NumberP970021
Supplement NumberS006
Date Received11/08/2002
Decision Date05/07/2003
Product Code
MKN[ Registered Establishments with MKN ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a material change to the silixone balloon. The device, as modified, will be marketed under the trade name gynecare thermachoice iii uterine balloon therapy system.
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