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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Supplement NumberS034
Date Received04/12/2011
Decision Date07/01/2011
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO REMOVE A CONTRAINDICATION AND TO REVISE A WARNING REGARDING NICKEL SENSITIVITY IN PHYSICIANS LABELING.
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