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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 Nametranscatheter patent ductus arterious occlusion device
PMA NumberP020024
Supplement NumberS005
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 duct occluder device with the following indications for use: the amplatzer duct occluder device is indicated for the non-surgical closure of patent ductus arteriosus (pda).