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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 UTERINE BALLOON THERAPY SYSTEM
Classification Namecatheter, balloon, transcervical
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE
PMA NumberP970021
Supplement NumberS007
Date Received01/13/2003
Decision Date03/27/2003
Product Code
MKN[ Registered Establishments with MKN ]
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 colorado medtech, inc. , boulder, colorado. The gynecare thermachoice controller will be manufactured at this facility.
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