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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.
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
5050 nathan lane north
plymouth, MN 55442
PMA NumberP020024
Supplement NumberS037
Date Received01/22/2013
Decision Date08/18/2013
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Clinical Trials NCT00713700
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the second generation amplatzer duct occluder ii (ado ii) device. The device, as modified, will be marketed under the trade name amplatzer duct occluder ii and is indicated for the non-surgical closure of patent ductus arteriosius (pda).
Post-Approval StudyShow Report Schedule and Study Progress