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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 ENDOMETERIAL ABLATION (MEA) SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMicrosulis Medical , Ltd.
Parklands Business Park
Denmead Hampshire PO7 6XP
PMA NumberP020031
Supplement NumberS001
Date Received03/09/2004
Decision Date05/25/2005
Withdrawal Date07/05/2011
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE SINGLE USE MEA APPLICATOR.
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