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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 WITH QWIK LOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter cardiac occlusion device
ApplicantNMT MEDICAL, INC.
PMA NumberP000049
Supplement NumberS015
Date Received08/13/2004
Decision Date09/13/2004
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the patient information card to include a revised mri compatibility statement that specifies that the compatibility testing was performed with a 1. 5 tesla magnetic field.
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