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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.
 
DeviceCONCEPTUS ESSURE SYSTEM
Classification Nameinsert, tubal occlusion
Generic Nameinsert, tubal occlusion
Regulation Number884.5380
Applicant
BAYER PHARMA AG
mollerstrabe 178
berlin 13353
PMA NumberP020014
Supplement NumberS024
Date Received01/30/2009
Decision Date08/26/2009
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate supplier for the wound inner/outer coil (precision wire components) of the device.
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