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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 NameTHERMA CHOICE UTERINE BALLON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE, A DIV. OF ETHICON, INC.
PMA NumberP970021
Supplement NumberS004
Date Received08/07/2000
Decision Date02/13/2001
Product Code
MNB[ Registered Establishments with MNB ]
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 to transfer the thermachoice catheter manufacturing operations to a new manufacturing facility located at ethicon, inc. , chihuahua, mexico.
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