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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 WITH QWIKLOAD
Generic NameTranscatheter septal occluder
ApplicantNmt Medical, Inc.
27 Wormwood St.
Boston, MA 02210
PMA NumberP000049
Supplement NumberS014
Date Received04/19/2004
Decision Date05/21/2004
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  
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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