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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 NumberS015
Date Received01/03/2024
Decision Date01/24/2024
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an update to a manufacturing procedure to provide an additional requirement for the silicone tubing for the Minerva ES Handpiece.
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