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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.
 
DeviceMICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMicrosulis Medical , Ltd.
Parklands Business Park
Denmead Hampshire PO7 6XP
PMA NumberP020031
Supplement NumberS002
Date Received07/12/2005
Decision Date10/14/2005
Withdrawal Date07/05/2011
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISED PATIENT LABELING.
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