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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
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
GYNECARE, INC.
p.o. box 151
sommerville, NJ 08876-0151
PMA NumberP970021
Supplement NumberS028
Date Received11/20/2009
Decision Date05/13/2010
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
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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