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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 NumberS003
Date Received03/13/2003
Decision Date04/11/2003
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO ADDRESS THE DIFFICULTY/FAILURE TO DISENGAGE OR DETACH THE DELIVERY WIRE FROM THE ESSURE MICRO-INSERT AND LABELING CHANGES TO STRENGTHEN THE RECOMMENDATION REGARDING USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) PRIOR TO THE ESSURE PROCEDURE.
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