| 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. |
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| Device | AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE |
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| Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
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| Applicant | ABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117 |
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| PMA Number | P000039 |
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| Supplement Number | S010 |
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| Date Received | 07/21/2005 |
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| Decision Date | 10/13/2005 |
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| Product Code |
MAE |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER Septal Occluder (ASO) Device with the following indications for use: 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). |
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