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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 3 UTERINE BALLOON THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGYNECARE, INC.
P.O. BOX 151
SOMMERVILLE, NJ 08876-0151
PMA NumberP970021
Supplement NumberS028
Date Received11/20/2009
Decision Date05/13/2010
Withdrawal Date 10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATED PROFESSIONAL LABELING TO REFLECT THE RESULTS OF THE POST-APPROVAL STUDY REQUIRED AS A CONDITION OF APPROVAL TO SUPPLEMENT 14.
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