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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 HELIX SEPTAL OCCLUDER, HX2015, HX2020, HX2025, HX2090, HX2095
Classification Nametranscatheter septal occluder
Generic Nameseptal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP050006
Supplement NumberS031
Date Received09/05/2012
Decision Date09/27/2012
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of alternate cutting equipment.
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