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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.
 
Trade NameAMPLATZER MUSCULAR VSD OCCLUDER
Classification Nametranscatheter septal occluder
Generic Namedevice transcatheter cardiac occlusion
ApplicantAGA MEDICAL CORP.
PMA NumberP040040
Supplement NumberS009
Date Received02/11/2009
Decision Date04/08/2009
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification in packaging materials and the use of a new sealer to accommodate the new packaging materials.
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