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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceADIANA PERMANENT CONTRACEPTION SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP070022
Date Received08/10/2007
Decision Date07/06/2009
Withdrawal Date 10/23/2012
Product Code KNH 
Docket Number 09M-0317
Notice Date 07/14/2009
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADIANA PERMANENT CONTRACEPTION SYSTEM. THE DEVICE IS INDICATED FOR WOMEN WHO DESIRE PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY OCCLUSION OF THE FALLOPIAN TUBES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S007 S008 S009 S010 S012 S013 S014 S016 S017 S018 S019 
S020 S021 S024 S028 S004 S005 S025 S026 S001 S006 S002 
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