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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
Generic NameTranscatheter septal occluder
ApplicantNmt Medical, Inc.
27 Wormwood St.
Boston, MA 02210
PMA NumberP000049
Supplement NumberS002
Date Received01/11/2002
Decision Date04/19/2002
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD.
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