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Device | AMPLATZER SEPTAL OCCLUDER AND MULTI-FENESTRATED SEPTAL OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S045 |
Date Received | 04/24/2012 |
Decision Date | 05/24/2012 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFY THE STATISTICAL SAMPLING PLAN FOR RECEIVING INSPECTIONS OF COMPONENTS OF THE SUBJECT DEVICES. |