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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 CONTRACEPTION SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantHOLOGIC, INC.
PMA NumberP070022
Supplement NumberS025
Date Received01/11/2012
Decision Date03/20/2012
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of the adiana rf generator to incorporate a touch screen user interface.
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