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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
PMA NumberP000039
Supplement NumberS010
Date Received08/02/2005
Decision Date10/13/2005
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to support compatibility of the devices with mr environments up to 3. 0 tesla. The device, as modified, will be marketed under the trade name amplatzer septal occluder (aso) device with the following indications for use: the amplatzer septal occluder (aso) device is indicated for the occlusion of atrial septal defects (asd) in secundum position. The aso device is also indicated in patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i. E. , 1. 5:1 degree of left to right shunt or rv enlargement).