|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 Name||CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL|
|Classification Name||insert, tubal occlusion|
|Generic Name||insert, tubal occlusion|
|Applicant||BAYER PHARMA AG|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to remove a contraindication and to revise a warning regarding nickel sensitivity in physicians labeling.