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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 NumberS005
Date Received09/25/2002
Decision Date10/23/2002
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing process of the device which involves the removal of the requirement for routine testing of anaerobic bacteria from nmt product bioburden procedure.
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