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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 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 NameESSURE SYSTEM
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantCONCEPTUS, INC.
PMA NumberP020014
Supplement NumberS008
Date Received09/20/2004
Decision Date01/31/2005
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a proposed packaging modification and subsequent changes to the ethylene oxide (eo) sterilization cycle and shelf life validation study.
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