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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 NumberS081
Date Received12/02/2020
Decision Date06/30/2021
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 design modifications of the cervical collar tip and the liner, addition of marking to the external sheath, change in color of front grip handle, new logo and tag, and labeling modifications.
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