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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received03/01/2005
Decision Date08/11/2006
Product Code
MLV[ Registered Establishments with MLV ]
Docket Number 06M-0341
Notice Date 08/25/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the gore helex septal occluder. The device is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closer of ostium secundum atrial septal defects (asds).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 
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