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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantBAYER HEALTHCARE LLC
PMA NumberP020014
Supplement NumberS041
Date Received03/14/2014
Decision Date06/29/2015
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Clinical Trials NCT01327105
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the essure instructions for use to replace the previously approved modified hysterosalpingogram confirmation test with the transvaginal ultrasound/ hysterosalpingogram confirmation test algorith.
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