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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namelaparoscopic contraceptive tubal occlusion device
Generic Namelaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
250 campus drive
marlborough, MA 01752
PMA NumberP070022
Date Received08/10/2007
Decision Date07/06/2009
Withdrawal Date 10/23/2012
Product Code
KNH[ Registered Establishments with KNH ]
Docket Number 09M-0317
Notice Date 07/14/2009
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S012 S013 S014 S016 S017 S018 S019 S020 S021 
S024 S025 S026 S028