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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.
 
Trade NameCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantCONCEPTUS, INC.
PMA NumberP020014
Supplement NumberS034
Date Received04/12/2011
Decision Date07/01/2011
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to remove a contraindication and to revise a warning regarding nickel sensitivity in physicians labeling.
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