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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 FOR PERMANENT BIRTH CONTROL
Classification Nametranscervical contraceptive tubal occlusion device
Generic Nametranscervical contraceptive tubal occlusion device
Regulation Number884.5380
Applicant
BAYER PHARMA AG
mollerstrabe 178
berlin 13353
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 - indications/instructions/shelf life/tradename
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
Post-Approval StudyShow Report Schedule and Study Progress
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