|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 Name||ADIANA PERMANENT CONTRACEPTION SYSTEM|
|Classification Name||device, occlusion, tubal, contraceptive|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| 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.