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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 NumberS002
Date Received05/08/2002
Decision Date06/05/2002
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MODIFICATIONS TO THE MANUFACTURING PROCESSES FOR THE NOVASURE DISPOSABLE DEVICE, INCLUDING INJECTION MOLDING OF THE PLASTIC COMPONENTS, INCORPORATION OF THE NON-CONDUCTING LINES OF THE ARRAY INTO THE PEAK II KNITTING PROCESS, AND THE INCORPORATION OF THREE SEPARATE TUBES INTO A SINGLE MULTI-LUMEN EXTRUSION.
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