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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 Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation system
ApplicantETHICON WOMEN'S HEALTH & UROLOGY
PMA NumberP970021
Supplement NumberS036
Date Received08/03/2011
Decision Date09/23/2011
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the material used to form the insulation layer of the thermocouple wires used within the balloon of the thermachoice uterine balloon therapy system.
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