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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.
 
DeviceTHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Generic NameCatheter, balloon, transcervical
ApplicantGynecare, Inc.
P.O. Box 151
Somerville, NJ 08876
PMA NumberP970021
Supplement NumberS006
Date Received11/08/2002
Decision Date05/07/2003
Withdrawal Date10/25/2016
Product Code MKN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MATERIAL CHANGE TO THE SILIXONE BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM.
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