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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 QWIKLOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter cardiac occlusion device
ApplicantNMT MEDICAL, INC.
PMA NumberP000049
Supplement NumberS014
Date Received04/19/2004
Decision Date05/21/2004
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 
Changes related to the implant fabric. The proposed changes involve transferring the fabric heat set and fabric cut steps to an alternate vendor.
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