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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.
 
DeviceADIANA PERMANENT CONTRACEPTION SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantHologic, Inc.
250 Campus Dr.
Malborough, MA 01752
PMA NumberP070022
Supplement NumberS024
Date Received10/13/2011
Decision Date11/23/2011
Withdrawal Date10/23/2012
Product Code KNH 
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 CHANGE TO THE ADIANA CATHETER TO INCREASE THE FLEXIBILITY FOR USE WITH HYSTEROSCOPES WITH ARTICULATING TIPS.
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