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Device | AMPLATZER SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S023 |
Date Received | 07/10/2007 |
Decision Date | 12/04/2007 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AGA MEDICAL CORPORATION TO BECOME THE PRIMARY SOURCE FOR THE LASER WELDING PROCESS, WHILE RETAINING THE CURRENT VENDOR AS A SECONDARY SOURCE. |