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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMinitouch 3.8 Era System (Minitouch System)
Generic NameDevice, thermal ablation, endometrial
ApplicantMicroCube, LLC
47853 Warm Springs Boulevard
Fremont, CA 94539
PMA NumberP230002
Date Received01/30/2023
Decision Date07/28/2023
Product Code MNB 
Docket Number 23M-3222
Notice Date 08/04/2023
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT04267562
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Minitouch 3.8 Era System (Minitouch System). This device is indicated for ablation of the endometrial lining of the uterus for the treatment of menorrhagia (heavy menstrual bleeding) due to benign causes in premenopausal women for whom childbearing is complete.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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