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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 CARDIOFORM SEPTAL OCCLUDER
Generic NameTranscatheter septal occluder
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP050006
Supplement NumberS044
Date Received11/03/2014
Decision Date04/30/2015
Product Code MLV 
Advisory Committee Cardiovascular
Clinical TrialsNCT00465270
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ADDITION OF THE GORE CARDIOFORM SEPTAL OCCLUDER TO THE GORE HELEX SEPTAL OCCLUDER LINE.
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