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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 NameESSURE SYSTEM
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantCONCEPTUS, INC.
PMA NumberP020014
Supplement NumberS006
Date Received12/08/2003
Decision Date07/22/2004
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of a warning statement in the essure physician labeling regarding thermal endometrial ablation in women with essure micro-inserts in place.
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