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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 III UTERINE BALLOON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
ApplicantGYNECARE, INC.
PMA NumberP970021
Supplement NumberS025
Date Received12/16/2008
Decision Date02/11/2009
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 modified tri-y, component of the balloon catheter, and a change to the raw material specification for the pressure tubing.
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