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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. ENDOMETRIAL ABLATION SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMinerva Surgical, Inc.
4255 Burton Drive
Santa Clara, CA 95054
PMA NumberP000040
Supplement NumberS002
Date Received10/09/2001
Decision Date12/07/2001
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 USING MOLDING AND EXTRUDING TECHNIQUES RATHER THAN MACHINING THE COMPONENTS THAT NMAKE UP THE DISPOSABLE SHEATH OF THE HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM.
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