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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 Dr.
Malborough, MA 01752
PMA NumberP010013
Supplement NumberS024
Date Received06/30/2009
Decision Date07/31/2009
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES INTENDED TO IMPROVE THE INSTRUCTIONS FOR USE BY ADDING A CONTRAINDICATION FOR USE IN PATIENTS WITH A METAL OBJECT IN THE UTERUS OR UTERINE CAVITY.
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