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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.
 
DeviceESSURE SYSTEM
Classification Nameinsert, tubal occlusion
Generic Nameinsert, tubal occlusion
Regulation Number884.5380
Applicant
BAYER PHARMA AG
mollerstrabe 178
berlin 13353
PMA NumberP020014
Supplement NumberS039
Date Received11/19/2012
Decision Date12/20/2012
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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