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Device | AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Date Received | 06/24/2002 |
Decision Date | 05/14/2003 |
Product Code |
MAE |
Docket Number | 06M-0075 |
Notice Date | 02/16/2006 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM. THE PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSUS (PDA). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 S028 S029 S030 S031 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S051 S052 S053 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 |