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Trade Name | Amplatzer Post-Infarct Muscular VSD Occluder |
Classification Name | transcatheter septal occluder |
Generic Name | transcatheter septal occluder |
Applicant |
Abbott Medical |
177 county road b east |
st. paul, MN 55117 |
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HDE Number | H070005 |
Supplement Number | S019 |
Date Received | 06/28/2021 |
Decision Date | 07/27/2021 |
Product Code | |
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 An update to the dome weld and end screw weld visual acceptance criteria. |