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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 THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGYNECARE, INC.
P.O. BOX 151
SOMMERVILLE, NJ 08876-0151
PMA NumberP970021
Supplement NumberS033
Date Received01/31/2011
Decision Date02/25/2011
Withdrawal Date 10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE CLEANING SOLUTION USED IN REMOVING RESIDUE FROM THE HEATING WIRE DURING THE MANUFACTURING PROCESS.
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