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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.
 
DeviceCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Supplement NumberS017
Date Received04/04/2008
Decision Date02/24/2012
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING. ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY.
Post-Approval StudyShow Report Schedule and Study Progress
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