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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.
 
DeviceESSURE SYSTEM
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Supplement NumberS045
Date Received02/25/2016
Decision Date04/28/2016
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT01327105
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modifications to the post-approval study protocol.
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