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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.
 
DeviceHYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantAxora Medical, Inc.
1 Independent Dr. Suite 2300
Jacksonville, FL 32202
PMA NumberP000040
Supplement NumberS008
Date Received05/15/2006
Decision Date06/23/2006
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) ADDITION OF THE LINEAR FLASH CARD MEMORY TO THE CENTRAL PROCESSING BOARD; 2) TEMPERATURE CONTROLLER PID SETTINGS/INCREASE IN CYCLE TIME PROGRAMMED INTO HEATER LOGIC AND CONTROLLER BOARD; AND 3) ADDITION OF COMPONENTS TO THE LEVEL SENSOR BOARD.
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