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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 NumberS020
Date Received06/29/2011
Decision Date08/09/2011
Withdrawal Date10/23/2012
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF THE ACCEPTANCE CRITERIA FOR THE DEPLOYMENT FORCE EXERTED ON A POLYURETHANE RING IN THE ADIANA CATHETER.
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