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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 NameGYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation system
ApplicantETHICON WOMEN'S HEALTH & UROLOGY
PMA NumberP970021
Supplement NumberS015
Date Received07/16/2007
Decision Date11/05/2007
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the ethylene oxide sterilization cycle.
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