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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.
 
DeviceAMPLATZER DUCT OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, MN 55442
PMA NumberP020024
Supplement NumberS005
Date Received07/21/2005
Decision Date10/13/2005
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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).
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