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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.
 
DeviceMinitouch 3.8 Era System (Minitouch System)
Generic NameDevice, thermal ablation, endometrial
ApplicantMicrocube, LLC
47853 Warm Springs Blvd.
Fremont, CA 94539
PMA NumberP230002
Supplement NumberS002
Date Received12/05/2025
Decision Date07/13/2026
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design modifications to the Minitouch System, including changes to the Handpiece manufacturing methods and changes to the Generator system architecture, hardware, and software to add additional risk control measures and provide an updated user interface.
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