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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 OCCULUSION SYSTEM WITH QWIK LOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter cardiac occlusion device
ApplicantNMT MEDICAL, INC.
PMA NumberP000049
Supplement NumberS011
Date Received03/02/2004
Decision Date03/24/2004
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process of the cardioseal septal occlusion system with qwik load which involves a change to the bioburden sampling plan to eliminate redundant quarterly testing.
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