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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 NumberS002
Date Received12/26/2007
Decision Date01/25/2008
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Applicant to be the primary source for the laser welding process, while retaining the current vendor as a secondary source.
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