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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 NumberS001
Date Received04/25/2024
Decision Date07/16/2024
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
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 that reflect the findings of the completed post-approval study (PAS) for the Minitouch 3.8 Era System (Minitouch System).
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