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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
ApplicantMinerva Surgical, Inc.
4255 Burton Drive
Santa Clara, CA 95054
PMA NumberP000040
Supplement NumberS009
Date Received11/07/2006
Decision Date03/23/2007
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO INCLUDE CLEANING, STERILIZATION AND REUSE INSTRUCTIONS FOR THE HTA SYSTEM SCOPE ADAPTORS IN A NEW PACKAGE INSERT AND IN THE HTA SYSTEM USER?S MANUAL.
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