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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 NameCARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter cardiac occlusion device
ApplicantNMT MEDICAL, INC.
PMA NumberP000049
Supplement NumberS007
Date Received11/25/2002
Decision Date12/23/2002
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 
Change in the manufacturing process to add an alternate vendor for the delivery system y-body assembly.
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