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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 W/QWIK LOAD
Generic NameTranscatheter septal occluder
ApplicantNmt Medical, Inc.
27 Wormwood St.
Boston, MA 02210
PMA NumberP000049
Supplement NumberS007
Date Received11/25/2002
Decision Date12/23/2002
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO ADD AN ALTERNATE VENDOR FOR THE DELIVERY SYSTEM Y-BODY ASSEMBLY.
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