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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 NumberS083
Date Received03/29/2021
Decision Date03/30/2021
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  
Consolidation of inspection test steps to reduce any over-manipulation of the devices in the manufacturing process and modification of the current inspection sampling method for the Array Liner and Array Sewing Assembly of the NovaSure Gen 4.1 devices from a defined sampling size to a credit sampling method.
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