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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantMICROSULIS MEDICAL LTD.
PMA NumberP020031
Supplement NumberS003
Date Received04/11/2008
Decision Date09/02/2008
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the instructions for use for the mea system to include the results of the long-term follow-up of study subjects.
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