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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 NumberS007
Date Received04/03/2017
Decision Date06/26/2017
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software changes to the Minerva Endometrial Ablation System (i.e., software modifications to 1) correct an error code during device start; 2) to redefine existing error codes to better align them with the observed device conditions; and 3) to add five software checks to the device).
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