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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/QWIKLOAD
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
NMT MEDICAL, INC.
27 wormwood st.
boston, MA 02210
PMA NumberP000049
Supplement NumberS004
Date Received05/20/2002
Decision Date06/19/2002
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE INCOMING INSPECTION FOR TYVEK/MYLAR POUCHES USED FOR PACKAGING THE IMPLANT AND DELIVERY SYSTEM.
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