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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGYNECARE, INC.
P.O. BOX 151
SOMMERVILLE, NJ 08876-0151
PMA NumberP970021
Supplement NumberS038
Date Received04/24/2013
Decision Date06/20/2013
Withdrawal Date 10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN PRESSURE TRANSDUCER.
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