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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.
 
DeviceHTA SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMinerva Surgical, Inc.
4255 Burton Drive
Santa Clara, CA 95054
PMA NumberP000040
Supplement NumberS013
Date Received02/13/2009
Decision Date05/14/2009
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SHEATH (A COMPONENT OF THE HTA SYSTEM) WHICH INCLUDE THE ADDITION OF THE CERVICAL SEAL ASSIST COMPONENT AND A REDESIGN OF THE RESERVOIR TIP. THE SHEATH, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTA PROCERVA PROCEDURE SHEATH.
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