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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, HX2015, HX2020, HX2025, HX2030, HX2035
Classification Nametranscatheter septal occluder
Generic Nameseptal occluder
PMA NumberP050006
Supplement NumberS032
Date Received10/12/2012
Decision Date11/07/2012
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a supplier for polyvinyl alcohol (pva).