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Device | AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S013 |
Date Received | 11/21/2005 |
Decision Date | 09/21/2006 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER (?CRIBRIFORM? OCCLUDER). THE DEVICE IS INDICATED FOR THE CLOSURE OF MULTI-FENESTRATED (CRIBRIFORM) ATRIAL SEPTAL DEFECTS. |