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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 NumberS001
Date Received09/12/2006
Decision Date09/21/2007
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications for the catheter delivery system (helix 1. 5 delivery system).
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