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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.
 
DeviceNOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP010013
Supplement NumberS004
Date Received12/24/2002
Decision Date01/16/2003
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 A MANUFACTURING AND MATERIAL CHANGE TO THE CERVICAL COLLAR COMPONENT OF THE DISPOSABLE DEVICE.
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