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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
Generic NameTranscatheter septal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085-1505
PMA NumberP050006
Supplement NumberS039
Date Received06/04/2014
Decision Date07/02/2014
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.
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