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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 NumberS006
Date Received07/18/2005
Decision Date09/21/2005
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 THE ADDITION OF THE TENACULUM STABILIZER COMPONENT TO THE HTA PROCEDURE SET AND FOR CHANGES TO THE PACKAGING, SHELF-LIFE AND LABELING ASSOCIATED WITH THE ADDITION OF THE COMPONENT.
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