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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 NameTHERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal ballo0n endometrial ablation
ApplicantGYNECARE, A DIV. OF ETHICON, INC.
PMA NumberP970021
Supplement NumberS005
Date Received08/28/2000
Decision Date10/19/2001
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to relocate device manufacturing due to the closure of the gynecare menlo park facility. Manufacturing will be performed at rela/colorado medtech, inc, longmont, colorado and at ethicon, inc. , somervile, new jersey.
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