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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 NumberS051
Date Received04/04/2018
Decision Date04/09/2018
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the title of the "Patient-Doctor Discussion Checklist" to "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement,” and for revisions to the patient insert card.
Approval Order Approval Order
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