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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARDIOSEAL SEPTAL OCCLUSION SYSTEM
Generic NameTranscatheter septal occluder
ApplicantNMT MEDICAL, INC.
27 WORMWOOD ST.
BOSTON, MA 02210
PMA NumberP000049
Supplement NumberS013
Date Received04/16/2004
Decision Date05/14/2004
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE VENDOR FOR THE DEVICE.
Post-Approval StudyShow Report Schedule and Study Progress
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