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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 SEPTAL OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
St. Jude Medical Cardiovascular Division
5050 nathan lane north
plymouth, MN 55442
PMA NumberP000039
Supplement NumberS002
Date Received03/12/2002
Decision Date05/03/2002
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a caution label.
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