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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 NumberS021
Date Received09/11/2008
Decision Date11/07/2008
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes to the essure system, i. E. , dimensional specification of the delivery wire holder; change to the release band positioning; and a change to the heat shrink tubing length.
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