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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
Somerville, NJ 08876
PMA NumberP970021
Supplement NumberS036
Date Received08/03/2011
Decision Date09/23/2011
Withdrawal Date10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE MATERIAL USED TO FORM THE INSULATION LAYER OF THE THERMOCOUPLE WIRES USED WITHIN THE BALLOON OF THE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM.
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