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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.
 
DeviceMinerva Endometrial Ablation System
Generic NameDevice, thermal ablation, endometrial
ApplicantAxora Medical, Inc.
1 Independent Dr. Suite 2300
Jacksonville, FL 32202
PMA NumberP140013
Supplement NumberS006
Date Received02/07/2017
Decision Date08/07/2017
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT01569763
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes to update the clinical study results to reflect the final 2- and 3-year follow-up results from the Minerva Single-Arm study, as well as the 1-year follow-up results from the Minerva Randomized Control Trial.
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