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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 NumberS078
Date Received09/30/2019
Decision Date10/01/2019
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  
Replace a Stoll CMS 340 knitting machine with a Stoll CMS 822 knitting machine.
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