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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 NumberS004
Date Received05/28/2010
Decision Date07/28/2010
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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