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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 OCCULUSION SYSTEM WITH QWIK LOAD
Generic NameTranscatheter septal occluder
ApplicantNmt Medical, Inc.
27 Wormwood St.
Boston, MA 02210
PMA NumberP000049
Supplement NumberS011
Date Received03/02/2004
Decision Date03/24/2004
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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