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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 UTERINE BALLOON THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGynecare, Inc.
P.O. Box 151
Somerville, NJ 08876
PMA NumberP970021
Supplement NumberS005
Date Received08/28/2000
Decision Date10/19/2001
Withdrawal Date10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO RELOCATE DEVICE MANUFACTURING DUE TO THE CLOSURE OF THE GYNECARE MENLO PARK FACILITY. MANUFACTURING WILL BE PERFORMED AT RELA/COLORADO MEDTECH, INC, LONGMONT, COLORADO AND AT ETHICON, INC., SOMERVILE, NEW JERSEY.
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