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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
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Supplement NumberS040
Date Received10/03/2013
Decision Date10/30/2013
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET TO INCLUDE ADDITIONAL INFORMATION ON RISKS OF CHRONIC PELVIC PAIN AND DEVICE MIGRATION.
Post-Approval StudyShow Report Schedule and Study Progress
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