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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTHE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
Classification Nametranscatheter septal occluder
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Date Received09/01/2000
Decision Date12/05/2001
Product Code
MLV[ Registered Establishments with MLV ]
Docket Number 02M-0271
Notice Date 06/27/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the amplatzer septal occluder (aso) and the amplatzer exchange system. The amplatzer septal occluder (aso) device is indicated for the occlusion of atrial septal defects (asd) in secundum position. The aso device is also indicated in patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i. E. , 1. 5:1 degree of left to right shunt or rv enlargement). The amplatzer exchange system is intended for the removal of an amplatzer delivery sheath and subsequent exchange for an amplatzer delivery sheath of equal or larger diameter.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 
S012 S013 S015 S016 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S032 S035 S036 S037 S038 S039 S041 S042 S043 
S045 S046 S047 S049 
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