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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGORE HELEX SEPTAL OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nameseptal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP050006
Supplement NumberS014
Date Received09/17/2009
Decision Date01/05/2011
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Clinical Trials NCT00581308
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updated device labeling.
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