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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAMPLATZER PFO OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
St. Jude Medical, Inc.
5050 nathan lane north
plymouth, MN 55442
PMA NumberP120021
Date Received11/30/2012
Decision Date10/28/2016
Product Code
MLV[ Registered Establishments with MLV ]
Docket Number 16M-3653
Notice Date 11/01/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00465270
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter closure of a 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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