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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGORE HELEX SEPTAL OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
W.L. GORE & ASSOCIATES,INC
32360 n north valley parkway
phoenix, AZ 85085-1505
PMA NumberP050006
Supplement NumberS042
Date Received06/04/2014
Decision Date07/02/2014
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
IMPLEMENTATION OF AN ADDITIONAL MOISTURE ANALYZER AND IMPLEMENTATION OF ADDITIONAL FUNCTIONALITY OF THE ANALYZER.
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