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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 85085-1505
PMA NumberP050006
Supplement NumberS060
Date Received07/31/2017
Decision Date03/30/2018
Product Code MLV 
Docket Number 18M-1372
Notice Date 04/17/2018
Advisory Committee Cardiovascular
Clinical TrialsNCT00738894
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the GORE CARDIOFORM Septal Occluder. The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum:1) ostium secundum atrial septal defects (ASDs); and2) patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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