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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 NumberS001
Date Received12/23/2002
Decision Date03/06/2003
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 A MODIFIED DELIVERY CATHETER CALLED THE COIL CATHETER AND A MODIFIED SPLIT INTRODUCER.
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