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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
PMA NumberP020031
Date Received07/24/2002
Decision Date09/23/2003
Withdrawal Date 07/05/2011
Product Code
MNB[ Registered Establishments with MNB ]
Docket Number 04M-0031
Notice Date 01/22/2004
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the microsulis microwave endometrial ablation (mea) system. The device is indicated for ablation of the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003