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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 ENDOMETERIAL ABLATION (MEA) SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantMICROSULIS MEDICAL LTD.
PMA NumberP020031
Supplement NumberS001
Date Received03/17/2004
Decision Date05/25/2005
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the single use mea applicator.
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