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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, MN 55442
HDE NumberH070005
Date Received06/18/2007
Decision Date01/10/2017
Product Code
MLV[ Registered Establishments with MLV ]
Docket Number 17M-0180
Notice Date 01/12/2017
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the amplatzer post-infarct muscular vsd occluder. The amplatzer post-infarct muscular vsd occluder is a percutaneous transcatheter occlusion device intended for closure of post myocardial infarct muscular ventricular septal defects in patients who are not satisfactory surgical candidates.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 
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