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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 NumberS022
Date Received01/09/2009
Decision Date04/20/2009
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the physician labeling precaution regarding magnetic resonance imaging of women with essure micro-inserts.
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