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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.
 
DeviceGENESYS HTA SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMinerva Surgical, Inc.
4255 Burton Drive
Santa Clara, CA 95054
PMA NumberP000040
Supplement NumberS014
Date Received05/06/2009
Decision Date04/23/2010
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ¿NEXT GENERATION¿ HTA SYSTEM WITH A REDESIGNED OPERATIONAL UNIT (CONTROL UNIT, POWER CORD, PEDESTAL, IV POLE) AND A MODIFIED STERILE PROCEDURE SET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GENESYS HTA SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
Post-Approval StudyShow Report Schedule and Study Progress
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