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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 septal occluder
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 Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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