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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 III UTERINE BALLOON THERAPY SYSTEM
Generic NameCatheter, balloon, transcervical
ApplicantGynecare, Inc.
P.O. Box 151
Somerville, NJ 08876
PMA NumberP970021
Supplement NumberS010
Date Received11/18/2003
Decision Date12/02/2003
Withdrawal Date10/25/2016
Product Code MKN 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS CORPORATION, ISOMEDIX SERVICES, EL PASO, TEXAS.
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