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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)
Generic NameDevice, thermal ablation, endometrial
ApplicantMicrosulis Medical , Ltd.
Parklands Business Park
Denmead Hampshire PO7 6XP
PMA NumberP020031
Supplement NumberS003
Date Received04/11/2008
Decision Date09/02/2008
Withdrawal Date07/05/2011
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
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 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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