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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 Device
Generic NameDevice, thermal ablation, endometrial
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP010013
Supplement NumberS077
Date Received09/23/2019
Decision Date09/26/2019
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change in the amount of antioxidant in the pellethane liner and a change of supplier of black ink used in the pellethane liner.
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