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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameADIANA PERMANENT CONTRACEPTION SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantHOLOGIC, INC.
PMA NumberP070022
Supplement NumberS020
Date Received06/29/2011
Decision Date08/09/2011
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
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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