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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 NumberS014
Date Received05/12/2005
Decision Date07/22/2005
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE DEVICE PERFORMANCE PROTOCOL USED TO ESTABLISH THE SHELF LIFE OF THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. THE PROTOCOL USED TO ASSESS PACKAGE INTEGRITY, I.E., PPQ-012, PREVIOUSLY APPROVED IS UNCHANGED.)
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