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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 NumberS004
Date Received05/28/2010
Decision Date07/28/2010
Withdrawal Date10/23/2012
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGING A CONTRAINDICATION IN THE ADIANA INSTRUCTION FOR USE TO REDUCE THE MINIMUM INTERVAL BETWEEN CONCLUSION OF A PREGNANCY AND THE ADIANA PROCEDURE FROM 12 WEEKS TO SIX WEEKS AND FOR ADDING A WARNING REGARDING INCOMPLETE UTERINE INVOLUTION.
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