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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.
 
DeviceESSURE SYSTEM
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBayer Pharma AG
Mollerstrabe 178
Berlin 13353
PMA NumberP020014
Supplement NumberS021
Date Received09/11/2008
Decision Date11/07/2008
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH.
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